Page last updated: 2024-12-05

benzoyl peroxide

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Description

Benzoyl peroxide is a synthetic organic compound with the formula (C6H5CO)2O2. It is a white, crystalline solid that is insoluble in water but soluble in most organic solvents. It is primarily used as an acne treatment, as it is an effective antibacterial and anti-inflammatory agent. Benzoyl peroxide works by killing the bacteria that cause acne and reducing inflammation. It also helps to prevent the formation of new acne lesions. Benzoyl peroxide is typically applied to the skin as a cream, lotion, or gel. It is available over-the-counter and by prescription. Side effects of benzoyl peroxide include dryness, redness, peeling, and irritation. It is important to use benzoyl peroxide as directed and to avoid contact with the eyes and mouth. Benzoyl peroxide is a powerful oxidizing agent and should be handled with care. It is also sensitive to light and should be stored in a cool, dry place.'

Benzoyl Peroxide: A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID7187
CHEMBL ID1200370
CHEBI ID82405
SCHEMBL ID63
MeSH IDM0002375

Synonyms (668)

Synonym
BIDD:GT0840
smr000058568
MLS000028899
benzoyl peroxide (jan/usp)
D03093
bepio (tn)
clearasil bp acne treatment cream
debroxide
benzac w
clearasil antibacterial acne lotion
dibenzoylperoxyde [dutch]
lucidol-70
akneroxide l
desquam-x
lucidol (peroxide)
acnegel
incidol
b 75w
desquam x
stri-dex b.p
cadox b 50p
benzoyl peroxide [usan]
garox
benzashave
cadox b 70w
dibenzoylperoxid [german]
nsc 671
cadox b
phisoac bp
clear by design
novadelox
oxy-5
desquam e
quinolor compound
benoxyl (5&10) lotion
topex
nayper b and bo
acne-aid cream
benbel c
vanoxide
xerac
benzaknen
luperox fl
cadox b-ch 50
bzf-60
brevoxyl
loroxide
ccris 630
aksil 5
benzoylperoxyde [dutch]
benzagel 10
hsdb 372
novadelox (18% benzoyl peroxide, 78% calcium sulphate, 4% magnesium carbonate)
epi clear antiseptic lotion
oxy-10
norox bzp-c-35
cadox 40e
desanden
cadox b 40e
cadat bpo
xerac bp
oxy-10 cover
luperco aa
perossido di benzoile [italian]
cadox bs
peroxyde de benzoyle [french]
norox bzp-250
benzagel
aztec bpo
lucidol 50p
superox 744
benox 50
lucidol kl 50
chaloxyd bp 50ft
abcat 40
einecs 202-327-6
fostex bpo
benzoylperoxid [german]
g 20
benzoyl
diphenylperoxyanhydride
benzoyl benzenecarboperoxoate
bpo ,
inchi=1/c14h10o4/c15-13(11-7-3-1-4-8-11)17-18-14(16)12-9-5-2-6-10-12/h1-10
benzoylperoxyde
component of oxy-5
nsc-671
lucidol g 20
panoxyl
persa-gel
mytolac
benzoic acid, peroxide
wln: rvoovr
benzoylperoxid
94-36-0
acetoxyl
asidopan
theraderm
oxy 5
peroxyde de benzoyle
nsc-675
eloxyl
benoxyl
dry and clear
persadox
benzac
dibenzoylperoxyde
diphenylglyoxal peroxide
dibenzoyl peroxide
akneroxid 5
oxylite
benzoyl peroxide
nsc671
nsc675
benzoperoxide
epi-clear
luperco ast
benzoyl superoxide
peroxide, dibenzoyl
dibenzoylperoxid
component of vanoxide
duresthin 5
lucidol b 50
resdan akne
perossido di benzoile
nayper bo
benzol peroxide
lucidol
luperox(r) atc50, benzoyl peroxide, ~50 wt. % in tricresyl phosphate
luperox(r) a75fp, benzoyl peroxide, 75% remainder water, contains 25 wt. % water as stabilizer, 75%
luperox(r) a75, benzoyl peroxide, 75%, remainder water
luperox(r) a70s, benzoyl peroxide, 70%, remainder water
NCGC00159380-04
NCGC00159380-02
NCGC00159380-03
peroxide, benzoyl
diphenylglyoxal superoxide
superoxide, benzoyl
superoxide, diphenylglyoxal
luperox(r) a98, benzoyl peroxide, reagent grade, >=98%
HMS2092F22
B3152
e928
anhydrous benzoyl peroxide
benzoylis peroxidum cum aqua
benzoyl peroxide anhydrous
chebi:82405 ,
CHEMBL1200370
epsolay
hydrous benzoyl peroxide
ins-928
ins no.928
e-928
AKOS000120600
A844933
benzenecarboperoxoic acid benzoyl ester
phenylcarbonyl benzenecarboperoxoate
NCGC00159380-05
C19346
cas-94-36-0
dtxcid001072
dtxsid6024591 ,
tox21_111619
nsc758205
nsc-758205
pharmakon1600-01503004
stri-dex b.p.
w9wzn9a0gm ,
benprox
benzoyl peroxide gel
neobenz micro
unii-w9wzn9a0gm
pacnex
fostex bpo bar, gel, and wash
benzoyl peroxide [usan:usp]
benzefoam
ec 202-327-6
lavoclen
SC10147
benzoyl peroxide component of benzamycin
duac component benzoyl peroxide
benzoyl peroxide [iarc]
hydrous benzoyl peroxide [usp monograph]
benzaclin component benzoyl peroxide
hydrous benzoyl peroxide [who-ip]
benzoyl peroxide component of epiduo
benzoyl peroxide component of acanya
benzoyl peroxide [who-dd]
idp-126 component benzoyl peroxide
benzoyl peroxide [inci]
benzoyl peroxide component of benzaclin
acanya component benzoyl peroxide
epiduo component benzoyl peroxide
benzoyl peroxide [hsdb]
benzoyl peroxide component of duac
benzoyl peroxide component of twyneo
benzamycin component benzoyl peroxide
benzoyl peroxide [jan]
benzoyl peroxide [mi]
twyneo component benzoyl peroxide
benzoyl peroxide [mart.]
benzoyl peroxide [usp impurity]
benzoylperoxide
benzoylis peroxidum cum aqua [who-ip latin]
benzoyl peroxide [fcc]
benzoyl peroxide [vandf]
benzoyl peroxide [orange book]
BP-21236
CCG-213090
SCHEMBL63
tox21_111619_1
dibenzoylperoxide
bezoyl peroxide
benzoyl peroxyde
benzoyl-peroxide
bisbenzoyl peroxide
dibenzoy lperoxide
bis benzoylperoxide
di-benzoylperoxide
benzoic peroxyanhydride
dibenzoyl-peroxide
bbpo
bzoobz
di-benzoyl peroxide
lucidol 70
dibenzoyl peroxyde
triaz
lucidol 78
sulfoxyl (salt/mix)
diphenylperoxyanhydride #
w 75
peroxyderm
clearasil bp acne treatment
nsc 675
un 2088
cadet bpo 78w
xerac bp (salt/mix)
lucidol 75fp
oxy wash
akneroxid l
xerac bp 5
na 2085 (dot)
nyper b
un 2085 (dot)
oxy-l
superox
luzidol
xerac bp 10
abcure s-40-25
preoxydex
un 2086
nyper bmt
benzagel (salt/mix)
component of vanoxide (salt/mix)
perkadox 20s
peroxydex
benzaknew
dermoxyl
cadet
clearasil benzoyl peroxide lotion
cuticura acne cream
sanoxit
nericur
fostex bpo (salt/mix)
2685-64-5
AB01562988_01
bepio
DB09096
mfcd00003071
benzoyl peroxide, 97% (dry wt.), wet with 25% water
F0001-2260
benzoyl peroxide, remainder water
sr-05000001817
SR-05000001817-1
benzoyl peroxide, saj first grade, >=98.0% dry basis
benzoyl peroxide blend with dicyclohexyl phthalate, technical, ~50% (t)
benzoyl peroxide, for synthesis, 72.0-80.0%
dibenzoylperoxid (german)
benzoyl peroxide (luperox(r) a75fp)
acetoxyl 2.5 and 5
periygel
lucidol-78
presadox
luperox a98
lucilite
luperco afr-250
luperco afr
luperco ac
aztec benzoyl peroxide-70-77
benzoyl peroxide (luperox(r) a98)
benzoyl peroxide (usp)
luperco a
benzoyl peroxide, blend in dibutyl phthalate
benzoyl peroxide (luperox(r) a70s)
benzoylperoxid (german)
benzoyl peroxide, blend in tricresyl phosphate
cadet bpo-70w
benzoyl peroxide, usan
benzoyl peroxide (usan)
lucidol gs
thermaderm
cadox btw-50
benzoyl peroxide (luperox(r) a75)
aztec benzoyl peroxide-dry
lucidol rm
cadox bta
novadeiox
lucipal
benzoyl peroxide(usan)
florox
benzoyl peroide
cadox bpo-w40
SBI-0206719.P001
triaz;dibenzoyl peroxide
Q411424
Z104489074
BRD-K59986511-001-02-3
peroxyl
BR1012
luperox(r) a75, benzoyl peroxide 75%, remainder water
androstan-17-one, 3-(acetyloxy)-5-bromo-6,19-epoxy-, (3b,5a,6b)-
breakout clearing emergency spot fix
relovox
meijer acne treatmentacne medication
spotless regimen for acne, blemishes and breakouts
benzoil 12hr acne treatment
skinpharmacy advanced acne therapy active clearing
dermaharmony 10% benzoyl peroxide
benzepro
replenix acne solution benzoyl peroxide wash
oil-free acne cleanser
walgreens acne control cleanser
breakout clearing daytime treatment
controlling cream
zapzyt acne
neutrogena acne control
medpura benzoyl peroxideaqueous base, acne treatment gel
o skin acne
lintera wash
oxy 10 acne cleanser
neutrogena clear pore cleanser mask
rugby benzoyl peroxideacne medication
oil free deep cleansing duo cleansing brush oil free acne cleanser
benzoyl perozide
md-acne body acne treatment
skinpharmacy advanced acne therapytargeted treatment wipes
rugby benzoyl peroxide
cetaphil gentle clear bpo acne cleanser
face values acne medication
terminator 10
benzoyl peroxide 2.50%
targeted acne spot treatmentcvs
ocean seas dermatology acne treatment cleanser
replenix acne
pca skin bpo cleanser
meijer maximum strength foaming acne face wash
acne vanishing gel-10%
acne face and body wash
dermisaclear skin
oxyadvanced care rapid spot treatment
benzoyl peroxide wash
o skin acne benzoyl wash
meijer acne foaming cleanser
acne spot repair
walgreens acne foaming washacne medication
lucidol 98
benzoyl peroxideacne medication
clear med10%
oxy 5tinted
oxy face washmaximum aciton
acne spot corrector
daily acne control cleanser
reform
cleanseracne clearing treatment
touch acne treatment
acne control serum
safewayacne treatment
vanishing acne treatment creamcvs health
oxy 10vanishing
acne free oil free acne cleanser 2.5 benzoyl peroxide
rodan and fieldsunblemish-acne medicated
family care acne treatment
benzoyl peroxide 5% gel
proactivextra strength formula treatment
slmd am benzoyl peroxide acne treatment
oxy face wash
skinpharmacy advanced acne therapy
bpo-3
meijer acne foaming cleanseracne treatment
bpt10.1 acne treatment
ca22 benzoyl peroxide cleansing
target up and up acne medication
slmd bp body wash
anti bac acne clearing
hydrous benzoyl peroxide (usp monograph)
skinpharmacy advanced acne therapy spot treatment
breakout controlbioelements
walgreens acne foaming cleanser
slmd spot treatment
24 hour acne serum
5 percent benzoyl peroxide cleanser
cvs health maximum strength acne treatment
solimo repairing treatment for acne prone skin
proactiv renewing cleanser
triderma acne spot treatment
sanperox bpo
acne10%
bp wash
benzoyl peroxide 4%
vanishing acne treatmentdaylogic
glossier zit stick breakout eraser
neutracure restore
acne therapy
acne forte acne treatment cream
neutrogena rapid clear stubborn acne cleanser
acne tx mask
3 step acne systemwell at walgreens
cleargenix advanced acne treatment
111 medco benzoyl peroxide
clear med
sacheu spot eraser
neutrogena stubborn acne am treatment
acne foaming washdaylodic
meijer maximum strength foaming acne face washacne medication
equate purifying cleanser
benzoazeline forte
equate acne washacne medication
oxy sensitive face washmaximum soothing
bevoline
rugby benzoyl peroxide wash
glytone acne bpo treatment gel
revitolacne treatment
breakout control
rugby acne medication benzoyl peroxide
blemish
af foam clear skin acne pore cleanser
lucidol bt 50
solimo renewing cleanser for acne prone skin
acne wipeout all day breakout control
avene cleanance acne medicated clearing treatment
creamy acne face wash
crmy acne washcvs
bp acne spot treatment
advanced acne wash
10% benzoyl peroxide acne medication
pr benzoyl peroxide wash
cvs health quick action spot treatment
superox 46-750
humane acne spot treatment
dermaharmony 5% benzoyl peroxide
advanced 3 in 1 exfoliating cleanser
acne free free 24 hr acne clearing system
all-in-one
rugby benzoyl peroxide washacne medication
bpt3.1 acne treatment
clear proof acne treatmentacne medication
dual-shave 2 in 1for her
acne solutionsclearing moisturizer acne medication
benzoyl peroxide 5%
vie naturelle acne body
tc 1 (peroxide)
cvs health concealing acne treatment maximum strength adult acne treatment
let me be perfectly clear
oxy rapid spot treatmentmaximum action
neutrogena on-the-spot acne treatmentvanishing formula
oxytotal care clarifying moisturizer
targeted acne spot treatment
clean and clear persa-gel 10
serious skincare continuously clear clearz it
spotless daily acne wash
daily leave on acne treatment mask
modesaacne treatment
dermaharmony 5% benzoyl peroxidecleansing bar
good neighbor pharmacy acne treatment
acne med 2.5%
oxy 10
naturium benzoyl peroxide cream cleanser 5%
proactiv plus pore targeting treatment
o skin acnemoderate
dr song acne
acne defense daily treatment serummerle norman
cvs health maximum strength acne treatmentacne medication
benzoyl peroxide (iarc)
equate clear complexion facial cleanser
lucidol bw 50t
spotless acne clearing treatment
pumice cleansing scrub-2.5% benzoyl peroxide
oxyadvanced care soothing cream acne cleanser
unblem est
obliterate
iblanc restora-brightacne healing
nyper bs
proactiv emergency blemish relief
benzoyl peroxide 4.00%
zapzyt acne treatment gel
amazon basics acne foaming cleanser
nyper ff-k
meijer invisible acne
perrigo benzoyl peroxidehydroalcoholic base
ab skincare acne spot treatment
benzoyl acne wash-2.5% benzoyl peroxide
smart release bpo5 percent
nyper bo
skin pharmacy advanced acne therapytargeted treatment wipes
glytone acne bpo clearing cleanser
walgreens acne foaming cleanseracne treatment
leader maximum strength invisible acne
asepxia acne treatment
dr acne wash facial cleanser
touch acne treatmentbenzoyl peroxide
cvs health acne control cleanser
pharmaskincare acnecare cleanser
meijer 3 step acne system
intensive face and body acne treatment
pca skin acne
zo skin health acne control benzoyl peroxide
bpo 4%
benzoyl peroxide cleanser
bpo 6%
healthy skin moisturizer
clean and clear continuous control acne cleanser
renewing clarifying cleanser
la roche posay laboratoire dermatologique effaclar duo acne treatment
unblemish
la roche-posay effaclar duo dual action acne treatment
benzefoam ultra
equate beauty acne foaming cleanser
kivoria acne wash
benzoly peroxide
unblemish dual intensive acne treatment
micronized bpo wash
neobenz(r) microbenzoyl peroxide wash, 7%
neutrogena on-the-spot acne treatment
equate repairing
phisoderm clear confidence spot treatment
paulas choice clear daily skin clearing treatment
bp spot treatment
dermisa acne treatment
on target
acne free severe acne 24 hr acne clearing system
walgreens 3 step acne system
smart release bpo10 percent
nyper bw
glytone acne 3p treatment gel
clear cell medicated acne scrub
proactivplus skin smoothing exfoliator
lucidol 40e
nyper bmt 40
maximum strength acne
benzoyl peroxide 2.5%
spot on treatment
cvs acne cleansing bar
zitfree
lucidol s 50
clear med5%
benzoyl peroxide 10%
benzoyl peroxide (mart.)
acne wipeout clinical acne system
signature care acne medication
foamimg acne face wash
differin max strength acne foaming bpo cleanser
nighttime control
benzoyl peroxide 5.0%
acne med 10%
dermaharmony 10% benzoyl peroxidecleansing bar
benzoyl peroxide 3%
clearasildaily clear tinted acne treatment
oxy on-the-go acne stick
breakout controlacne treatment
acne treatment serum
benzoyl peroxide serum
oxy sensitive face wash
special clearing booster
complexion clear acne treatment rejuvenating
oxy 5vanishing
equate acne wash
cadox b 75w
cadet bpo
gnp acne treatment
medpura benzoyl peroxide
lucidol ch 50
acne control cleanser
benzoyl peroxide plus medicated
micronized bpo scrub
oxy 10tinted
benzepro creamy wash
equate maximum strength spot treatment
acne face and body
bio-scriptives repiderm
clarifying face and body wash
2.5 acne med
age intervention duality md
humane acne wash
foaming acne face washwalgreens
davis benzoyl peroxide
clearasildaily clear vanishing acne treatment
benzoyl peroxide, 7%
caraderma
clear cell clarifying acne
clearx 3 blemish creme
dr. throwers bpo 5
vanishing acnecvs
micronized benzoyl peroxide treatment
meijer acne treatment
mdacne customized cream (benzoyl peroxide)
tula skincare go away acne spot treatment
clearasil stubborn acne control 5in1 spot treatment
winco foods maximum strength acne treatment
benzoyl peroxide deep cleansing foaming wash
clearasil stubborn acne control 5in1 concealing treatment
hyr acne wash
cerave acne foaming cleanser
pharmaskincare acnecare dermacontrol cream
benzoyl peroxide moisturizer
peroxido de benzoilo
dermaclear purity cleanser level ii
walgreens acne foaming wash
myhelper
maximum strength acne spot treatmentcvs health
nyper ff
benzoyl peroxide (usp impurity)
acne vanishing gel-5%
acne wipeout clear pore oil-free cleanser
acne solutionsemergency
acne spot correctormaximum strength
acne med 5%
acne cleansing bar
blemish correcting serum
neutrogena rapid clear stubborn acne spot
skin pharmacy advanced acne therapy
theraspecacne cleanser
10 acne med
acne gel
oc eight
acne defense daily treatment serum
bpo 8%
walgreens maximum strength tinted acne spot treatment cream
equate beauty acne cleansing bar
vetergen benzoyl peroxide
dermaclear purity cleanser level i
walgreens maximum strength acne gel
proactiv repairing treatment
dr. lin skincare acne
5 acne med
replenix acne solutions wash
clean and clear persa-gel 10 maximum strength
cvs health acne control cleanseracne medication
monat acne treatment
clear complexion acne serum
skincoach treat
clenziderm therapeutic
clear proof acne treatment
age intervention duality
family dollar acne treatment
dual-shave 2 in 1
nyper ns
glo skin beauty clear skin spot treatment
meijer invisible acneacne medication
target up and up 3 step acne system
lucidol w 40
benzoyl peroxide 10% gel
acnecare dermacontrol cream
benzoyl-plus moisturizing benzoyl peroxide
zitfreeacne treatment
dermaclear spot treatment
neobenz micro plus pack
oxyadvanced care sensitive skin acne cleanser
oxy rapid spot treatment

Research Excerpts

Overview

Benzoyl peroxide (BPO) is a cornerstone of acne therapy, often used in combination with a topical antibiotic and/or a retinoid. Evidence regarding its effectiveness as prophylaxis in shoulder surgery is lacking.

ExcerptReferenceRelevance
"Benzoyl peroxide (BPO) is a commonly used flour whitener, but its excessive usage can have adverse effects on human health, such as nutrient loss, vitamin deficiencies and certain diseases. "( An intelligent smartphone-test strip detection platform for rapid and on-site sensing of benzoyl peroxide in flour samples.
Fan, J; Feng, X; Li, R; Liu, X; Luo, L; Zhang, X; Zhao, B, 2023
)
2.57
"Benzoyl peroxide soap is a treatment for acne, but evidence regarding its effectiveness as prophylaxis in shoulder surgery is lacking."( Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients.
Gong, D; Hsu, JE; Matsen, FA; Napierala, MA; Whitson, AJ; Woodhead, BM, 2020
)
1.52
"Benzoyl peroxide (BPO) is a widely used over-the-counter (OTC) topical acne treatment often used in combination with salicylic acid (SA) to achieve better comedone control than that achieved with BPO alone. "( Evaluation of the efficacy, tolerability, and safety of an over-the-counter acne regimen containing benzoyl peroxide and salicylic acid in subjects with acne.
Butners, V; Eastern, J; Green, LJ; Gwazdauskas, J; Kircik, LH, 2013
)
2.05
"Benzoyl peroxide (BPO) is a cornerstone of acne therapy, often used in combination with a topical antibiotic and/or a retinoid. "( Tolerability and irritation potential of four topical acne regimens in healthy subjects.
Grove, G; Gwazdauskas, J; Zerweck, C, 2013
)
1.83
"Benzoyl peroxide (BPO) is a commonly used and highly effective topical treatment for acne that is available in concentrations from 2.5-10%. "( Benzoyl peroxide development, pharmacology, formulation and clinical uses in topical fixed-combinations.
Harper, JC, 2010
)
3.25
"Benzoyl peroxide (BPO) is a strong oxidizing agent and widely used as flour bleaching agent. "( Effects of flour bleaching agent on mice liver antioxidant status and ATPases.
Jia, X; Liu, P; Wu, Y, 2011
)
1.81
"Benzoyl peroxide (BPO) is a commonly used drug in the treatment of acne vulgaris, but it induces unwanted side effects related to stratum corneum (SC) function. "( Topical alpha-tocotrienol supplementation inhibits lipid peroxidation but fails to mitigate increased transepidermal water loss after benzoyl peroxide treatment of human skin.
Han, N; Luu, C; Packer, L; Thiele, JJ; Valacchi, G; Weber, S; Weber, SU, 2003
)
1.97
"Benzoyl peroxide (BP) is a first-line topical treatment in acne vulgaris (AV). "( Efficacy and safety of stabilised hydrogen peroxide cream (Crystacide) in mild-to-moderate acne vulgaris: a randomised, controlled trial versus benzoyl peroxide gel.
Bigardi, A; Milani, M; Zavattarelli, M, 2003
)
1.96
"Benzoyl peroxide (BP) is an initiator of polymerisation used in the synthesis of methyl methacrylate dental materials, and is a known allergen that causes allergic contact dermatitis during occupational exposure, especially in dentists and dental personnel. "( Presenting an in vitro cell culture model to determine the cytotoxic effect of benzoyl peroxide vapours.
Bester, MJ; Erasmus, F; Pretorius, E, 2003
)
1.99
"Benzoyl peroxide is a non-antibiotic antibacterial agent that is bactericidal against P."( Topical antibacterial treatments for acne vulgaris : comparative review and guide to selection.
Tan, HH, 2004
)
1.04
"Benzoyl peroxide is a free-radical generating compound widely used in the polymer industry and also in pharmaceuticals as antimicrobial agent to treat acne. "( Effect of alpha-tocopherol and N-acetylcysteine on benzoyl peroxide toxicity in human keratinocytes.
Albertazzi, A; Bellei, E; Bergamini, S; Iannone, A; Manfredini, P; Rota, C; Tomasi, A, 2004
)
2.02
"Benzoyl peroxide is a powerful antimicrobial agent that rapidly destroys both bacterial organisms and yeasts."( Topical antibacterial therapy for acne vulgaris.
Dreno, B, 2004
)
1.04
"Benzoyl peroxide was found to be a potent promoter as reported previously."( Studies on the promoting and complete carcinogenic activities of some oxidizing chemicals in skin carcinogenesis.
Hayashi, Y; Imazawa, T; Kurokawa, Y; Matsushima, Y; Takamura, N, 1984
)
0.99
"Benzoyl peroxide is a powerful oxiding agent with broad spectrum germicidal activity and good liposolubility. "( Utility of topical benzoyl peroxide for prevention of surgical skin wound infection.
Bencini, PL; Galimberti, M; Signorini, M, 1994
)
2.06
"Benzoyl peroxide (BzPO) is a free radical generating compound that acts as a tumor promoter and progressor in mouse skin. "( Generation of DNA base modification following treatment of cultured murine keratinocytes with benzoyl peroxide.
Egner, PA; Kensler, TW; King, JK, 1996
)
1.96
"Benzoyl peroxide is a known tumor promoter and progression agent in mouse skin, though it is not an initiator or complete carcinogen. "( Benzoyl peroxide-induced damage to DNA and its components: direct evidence for the generation of base adducts, sugar radicals, and strand breaks.
Davies, MJ; Hazlewood, C, 1996
)
3.18
"Benzoyl peroxide (BPO) is an effective cutaneous tumor promoter acting through the generation of oxidative stress, induction of ornithine decarboxylase activity and by enhancing DNA synthesis."( Attenuation of benzoyl peroxide-mediated cutaneous oxidative stress and hyperproliferative response by the prophylactic treatment of mice with spearmint (Mentha spicata).
Alam, A; Saleem, M; Sultana, S, 2000
)
1.38
"Benzoyl peroxide is an effective cutaneous tumor promoter acting through the generation of oxidative stress, the induction of ornithine decarboxylase activity and the enhancement of DNA synthesis."( Lupeol, a triterpene, inhibits early responses of tumor promotion induced by benzoyl peroxide in murine skin.
Ahmed, B; Alam, A; Arifin, S; Saleem, M; Shah, MS; Sultana, S, 2001
)
1.26
"Benzoyl peroxide is a bleaching agent typically used to give such flour a better appearance."( Determination of benzoyl peroxide and benzoic acid levels by HPLC during wheat flour bleaching process.
Fritz, R; Manrique, GD; Saiz, AI, 2001
)
1.37
"Benzoyl peroxide is a useful agent in the treatment of acne, chronic ulcers, tinea pedis, and tinea versicolor, probably because of its antimicrobial power. "( New uses for benzoyl peroxide: a broad-spectrum antimicrobial agent.
Kligman, AM; Leyden, JJ; Stewart, R, 1977
)
2.07
"Benzoyl peroxide is a powerful antibacterial agent."( [Acne and its drug treatment].
Büchner, SA, 1990
)
1
"Benzoyl peroxide (BP) is shown to be a weak allergen. "( Allergic and irritant potential of benzoyl peroxide.
Haustein, UF; Tegetmeyer, L; Ziegler, V, 1985
)
1.99

Effects

Benzoyl peroxide has a proven track record of safety and efficacy. It can decrease reliance on antibiotics in the treatment of acne.

Benzoyl peroxide (BPO) has been used extensively in industry and health care for more than a century and has been approved for the treatment of acne for over 60 years. It has antibiotic activity as well as anticomedogenic properties.

ExcerptReferenceRelevance
"Benzoyl peroxide has a proven track record of safety and efficacy, and can decrease reliance on antibiotics in the treatment of acne."( Advancement in benzoyl peroxide-based acne treatment: methods to increase both efficacy and tolerability.
Fakhouri, T; Feldman, SR; Yentzer, BA, 2009
)
1.43
"Benzoyl peroxide has a proven track record of safety and efficacy for the treatment of acne. "( Advancement in benzoyl peroxide-based acne treatment: methods to increase both efficacy and tolerability.
Fakhouri, T; Feldman, SR; Yentzer, BA, 2009
)
2.15
"Benzoyl peroxide (BPO) has been used extensively in industry and health care for more than a century and has been approved for the treatment of acne for over 60 years. "( Sixty Years of Benzoyl Peroxide Use in Dermatology.
Baldwin, H; Elewski, B; Hamil, K; Harper, J; Hougeir, F; Levy-Hacham, O; Yamauchi, P, 2023
)
2.71
"Benzoyl peroxide (BPO) has been widely used to treat acne vulgaris. "( [Mechanism of Inhibitory Effects of Cherry Bark-containing Jumihaidokuto on Benzoyl Peroxide Induced Erythema in Hairless Mice].
Han, LK; Michihara, S; Sejima, T; Takahashi, R; Zhang, Q, 2020
)
2.23
"Benzoyl peroxide (BPO) has been well established as a common medication for acne vulgaris in many countries (e.g. "( Clinical efficacy and safety of benzoyl peroxide for acne vulgaris: Comparison between Japanese and Western patients.
Doi, M; Kawashima, M; Nagare, T, 2017
)
2.18
"Benzoyl peroxide (BPO) has been a mainstay of topical acne treatment for years. "( Skin delivery aspects of benzoyl peroxide-loaded solid lipid nanoparticles for acne treatment.
Barhate, GA; Bhosale, SH; Kyadarkunte, AY; Mendiratta, C; Pokharkar, VB, 2014
)
2.15
"Benzoyl peroxide has a proven track record of safety and efficacy, and can decrease reliance on antibiotics in the treatment of acne."( Advancement in benzoyl peroxide-based acne treatment: methods to increase both efficacy and tolerability.
Fakhouri, T; Feldman, SR; Yentzer, BA, 2009
)
1.43
"Benzoyl peroxide has a proven track record of safety and efficacy for the treatment of acne. "( Advancement in benzoyl peroxide-based acne treatment: methods to increase both efficacy and tolerability.
Fakhouri, T; Feldman, SR; Yentzer, BA, 2009
)
2.15
"Benzoyl peroxide has antibiotic activity as well as anticomedogenic properties."( A randomized, double-blind, multicenter, parallel group study to compare relative efficacies of the topical gels 3% erythromycin/5% benzoyl peroxide and 0.025% tretinoin/erythromycin 4% in the treatment of moderate acne vulgaris of the face.
Amin, S; Choi, K; Goldstein, E; Gupta, AK; Kunynetz, RA; Lynde, CW,
)
1.06
"Benzoyl peroxide (BP) has been a standard and effective topical treatment for acne vulgaris for the past 35 years. "( Delayed type hypersensitivity to benzoyl peroxide.
Lowenstein, EJ; Shwereb, C,
)
1.86
"Benzoyl peroxide (BPO) has been an important component of the acne treatment armamentarium for decades. "( New developments in topical antimicrobial therapy for acne.
Leyden, J, 2008
)
1.79
"Benzoyl peroxide (BzPO) has been the most widely used topical agent for acne since the 1960s. "( Effect of benzoyl peroxide on protein kinase C in cultured human epidermal keratinocytes.
DeLeo, VA; Matsui, MS; Mintz, E, 1995
)
2.14
"Benzoyl peroxide also has antimicrobial, antipruriginous and antifungal properties all of them contributing to shorten the evolution of the lesions."( [Benzoyl peroxide in the treatment of decubitus ulcers].
Almenara Barrios, J; Alonso Blasi, N; Alonso Trujillo, F; Fernández Vozmediano, JM; Lafuente, L, 1988
)
1.91

Actions

Benzoyl peroxide caused an increase of 10.5% in sebum production on the forehead, 10.3% on the chin and 25.4% on the cheek.

ExcerptReferenceRelevance
"Benzoyl peroxide formulations suppress the follicular population of P. "( Comparative efficacy of clindamycin and benzoyl peroxide for in vivo suppression of Propionibacterium acnes.
Gans, EH; Kligman, AM, 2002
)
2.02
"Benzoyl peroxide caused an increase of 10.5% in sebum production on the forehead, 10.3% on the chin and 25.4% on the cheek."( Relationship between sebostatic activity, tolerability and efficacy of three topical drugs to treat mild to moderate acne.
Bragadin, G; Patrone, P; Pillon, B; Stinco, G; Trotter, D, 2007
)
1.06

Treatment

Benzoyl peroxide treatment (20 mg/animal/0.2 ml acetone) and UVB radiation (0.420 J/m(2)/s) caused a decrease in the activities of cutaneous antioxidant enzymes. Treatment with benzoylperoxide 5%/clindamycin phosphate 1% gel significantly reduced P acnes levels by >1 log10/cm2 from baseline.

ExcerptReferenceRelevance
"Benzoyl peroxide soap is a treatment for acne, but evidence regarding its effectiveness as prophylaxis in shoulder surgery is lacking."( Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients.
Gong, D; Hsu, JE; Matsen, FA; Napierala, MA; Whitson, AJ; Woodhead, BM, 2020
)
1.52
"Benzoyl peroxide treatment (20 mg/animal/0.2 ml acetone) and UVB radiation (0.420 J/m(2)/s) caused a decrease in the activities of cutaneous antioxidant enzymes namely, catalase, glutathione peroxidase, glutathione reductase, glucose-6-phosphate dehydrogenase, phase II metabolizing enzyme such as glutathione-S-transferase and quinone reductase and depletion in the level of cutaneous glutathione."( Inhibition of benzoyl peroxide and ultraviolet-B radiation induced oxidative stress and tumor promotion markers by cycloartenol in murine skin.
Alam, A; Khan, N; Sharma, S; Sultana, S, 2003
)
1.4
"Benzoyl peroxide treatment alone caused less marked increases in epidermal and dermal measures compared with ultraviolet B under the conditions used."( The effects of radicals compared with UVB as initiating species for the induction of chronic cutaneous photodamage.
Ibbotson, SH; Kochevar, IE; Moran, MN; Nash, JF, 1999
)
1.02
"Benzoyl peroxide treatment increases cutaneous microsomal lipid peroxidation and hydrogen peroxide generation."( Lupeol, a triterpene, inhibits early responses of tumor promotion induced by benzoyl peroxide in murine skin.
Ahmed, B; Alam, A; Arifin, S; Saleem, M; Shah, MS; Sultana, S, 2001
)
1.26
"Treatment with benzoyl peroxide 5%/clindamycin phosphate 1% gel significantly (P<.001) reduced P acnes levels by >1 log10/cm2 from baseline (91% inhibition) 24 hours after application."( Effect of topical benzoyl peroxide/clindamycin versus topical clindamycin and vehicle in the reduction of Propionibacterium acnes.
Leyden, JJ, 2002
)
0.99
"Treatment with benzoyl peroxide and the combination of erythromycin and benzoyl peroxide resulted in a significant reduction in the number of aerobic bacteria without any change in the resistance pattern to erythromycin or other antibiotics."( Antibiotic resistance patterns in coagulase-negative staphylococci after treatment with topical erythromycin, benzoyl peroxide, and combination therapy.
Foglia, AN; Fried, F; Harkaway, KS; Lee, WL; Leyden, JJ; McGinley, KJ; Shalita, AR, 1992
)
0.84
"The treatment with benzoyl peroxide alone leads to both a generalized hyperpigmentation and skin scaling without formation of any tumors."( Benzoyl peroxide promotes the formation of melanotic tumors in the skin of 7,12-dimethylbenz[a]anthracene-initiated Syrian golden hamsters.
Edler, L; Goerttler, K; Loehrke, H; Schweizer, J, 1987
)
2.03

Toxicity

benzoyl peroxide has been used in the treatment of acne for over 30 years. No reports of adverse effects that could be related to skin carcinogenesis. The most frequent adverse effect, dry skin, occurred to a similar extent in both treatment groups.

ExcerptReferenceRelevance
" A broad spectrum of model toxic compounds was evaluated for toxicity on mouse skin JB6 cells in culture."( Studies of skin toxicity in vitro: dose-response studies on JB6 cells.
Berezesky, IK; Fitzpatrick, MJ; Jain, PT; Phelps, PC; Trump, BF, 1992
)
0.28
"Topical benzoyl peroxide has been used in the treatment of acne for over 30 years, with no reports of adverse effects that could be related to skin carcinogenesis."( Benzoyl peroxide: an integrated human safety assessment for carcinogenicity.
Binder, RL; Kraus, AL; LeBoeuf, RA; Munro, IC; Orr, JC; Williams, GM, 1995
)
2.17
"3%) adverse event with all three therapies."( The efficacy and safety of a combination benzoyl peroxide/clindamycin topical gel compared with benzoyl peroxide alone and a benzoyl peroxide/erythromycin combination product.
Hickman, JG; Jarratt, MT; Levy, SF; Leyden, JJ; Stewart, DM,
)
0.4
" The most frequent adverse effect, dry skin, occurred to a similar extent in the combination and benzoyl peroxide treatment groups."( Comparison of the efficacy and safety of a combination topical gel formulation of benzoyl peroxide and clindamycin with benzoyl peroxide, clindamycin and vehicle gel in the treatments of acne vulgaris.
Berger, RS; Connolly, MA; Dunlap, FE; Ellis, CN; Levy, SF; Leyden, JJ, 2001
)
0.75
" Reported and theoretical adverse effects from systemic exposure are detailed."( Topical acne drugs: review of clinical properties, systemic exposure, and safety.
Akhavan, A; Bershad, S, 2003
)
0.32
" Adverse events were rare in all subjects."( Compared efficacy and safety of tretinoin 0.1% microsphere gel alone and in combination with benzoyl peroxide 6% cleanser for the treatment of acne vulgaris.
Anderson, DN; Landow, S; Lee, WL; Rafal, ES; Shalita, AR; Yavel, R, 2003
)
0.54
" Furthermore, the authors concluded that the permanent L929 mouse fibroblast cell line can provide valuable information regarding the cytotoxic effects of dental products and associated compounds that form toxic vapours."( Presenting an in vitro cell culture model to determine the cytotoxic effect of benzoyl peroxide vapours.
Bester, MJ; Erasmus, F; Pretorius, E, 2003
)
0.55
" The safety assessment was conducted through reports regarding adverse reactions and local tolerance in all visits and an overall tolerance at the end of the study."( Single-blind and comparative clinical study of the efficacy and safety of benzoyl peroxide 4% gel (BID) and adapalene 0.1% Gel (QD) in the treatment of acne vulgaris for 11 weeks.
de C Almeida, F; de Faria, FA; do Nascimento, LV; Guedes, AC; Guerra, RM; Magalhães, GM, 2003
)
0.55
" Evaluations included lesion count reduction, subject's assessment of acne, adverse events, and cutaneous tolerability."( Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris.
Gold, MH; Graeber, M; Liu, Y; Morris, A; Pariser, DM; Westmoreland, P, 2007
)
0.56
" Discontinuations due to adverse events were low (2."( Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris.
Gold, MH; Graeber, M; Liu, Y; Morris, A; Pariser, DM; Westmoreland, P, 2007
)
0.56
"These findings are consistent with previous clinical findings and support the use of a once-daily adapalene/BP fixed-dose combination as a safe and effective treatment in the long-term management of acne."( Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris.
Gold, MH; Graeber, M; Liu, Y; Morris, A; Pariser, DM; Westmoreland, P, 2007
)
0.56
" No substantive differences were seen in cutaneous tolerability among treatment groups and less than 1% of patients discontinued treatment because of adverse events."( An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efficacy and safety in 2813 patients.
Calvarese, B; Chen, D; Thiboutot, D; Webster, G; Weiss, J; Zaenglein, A, 2008
)
0.58
" While both regimens were safe and effective, regimen BPO/C+RAM yielded a more rapid onset of effect versus regimen CPT+BPO against both non-inflammatory and inflammatory lesions."( Comparative efficacy and safety results of two topical combination acne regimens.
Kircik, LH, 2009
)
0.35
" Our results show that BPO and the combination of BPO and clindamycin do not accelerate photocarcinogenesis, but are toxic in hairless mice."( Photocarcinogenesis and toxicity of benzoyl peroxide in hairless mice after simulated solar radiation.
Lerche, CM; Philipsen, PA; Poulsen, T; Wulf, HC, 2010
)
0.64
" Treatment-related adverse events (AEs) occurred in 48."( Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris.
Alió, AB; Barnard, J; Fischer, TC; Wohlrab, J; Zouboulis, CC, 2009
)
0.35
"We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products."( Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for over-the-counter human use; final rule.
, 2010
)
0.92
" The morning/morning regimen is a safe and effective treatment option for patients with moderate acne vulgaris."( Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen.
Bucko, A; Fried, R; Jarratt, MT; Kempers, S; Kircik, L; Lucky, AW; Nighland, M; Pariser, D; Rafal, E; Ramaswamy, R; Rendon, M; Rossi, AB; Weiss, J; Wilson, DC, 2010
)
0.62
"5% (adapalene-BPO) is efficacious and safe in the treatment of acne patients aged 12 years or older, as demonstrated in three randomized and controlled studies."( Treatment of 2,453 acne vulgaris patients aged 12-17 years with the fixed-dose adapalene-benzoyl peroxide combination topical gel: efficacy and safety.
Dirschka, T; Eichenfield, LE; Graeber, M; Jorizzo, JL; Kerrouche, N; Lynde, C; Taub, AF, 2010
)
0.58
" We report the fourth published case of acne vulgaris treated with isotretinoin in an individual with CGD, with a safe and successful outcome."( Safe and successful treatment of acne vulgaris with isotretinoin in a patient with chronic granulomatous disease.
Alonso-de-Celada, RM; de-Lucas Laguna, R,
)
0.13
" Safety assessments included skin tolerability and adverse events (AEs)."( Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study.
Alió Sáenz, AB; Eichenfield, LF, 2011
)
0.62
" Cutaneous adverse events were not statistically different in using combination therapy compared with T/CP alone."( Efficacy and safety of tretinoin 0.025%/clindamycin phosphate 1.2% gel in combination with benzoyl peroxide 6% cleansing cloths for the treatment of facial acne vulgaris.
Haddican, M; Linkner, RV; Wong, V; Zeichner, JA, 2013
)
0.61
" Safety was assessed through evaluations of adverse events (AEs) and local tolerability [erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)]."( Preadolescent moderate acne vulgaris: a randomized trial of the efficacy and safety of topical adapalene-benzoyl peroxides.
Draelos, Z; Eichenfield, LF; Hebert, AA; Liu, H; Lucky, AW; Manna, V; Rudisill, D; Stein Gold, L; Sugarman, J, 2013
)
0.6
" The changes of acne lesion count (efficacy), any adverse effect (safety), and the patients' overall satisfaction (tolerability) were compared after 3 months of follow-up."( The efficacy, safety, and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris: a randomized trial.
Babaeinejad, SH; Fouladi, RF, 2013
)
0.63
" The changes of acne lesion count (efficacy), any adverse effect (safety), and the patients' overall satisfaction (tolerability) were compared after 3 months of follow-up."( The efficacy, safety and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris; a randomized trial.
Babaeinejad, SH; Fouladi, RF, 2013
)
0.63
" Based on the results from this analysis, adapalene-BPO is a safe and effective treatment for acne in black skin."( A subgroup analysis to evaluate the efficacy and safety of adapalene-benzoyl peroxide topical gel in black subjects with moderate acne.
Alexis, AF; Callender, VD; Johnson, LA; Kerrouche, N, 2014
)
0.64
"A topical fixed-dose clindamycin phosphate 1·2% and benzoyl peroxide 3·0% combination gel (CLNP/BPO 3%) is known to be effective and safe in white people with acne."( Clindamycin phosphate 1·2%-benzoyl peroxide 3·0% fixed-dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single-blinded, acti
Alió Sáenz, AB; Hashimoto, H; Kawashima, M; Ono, M; Yamada, M, 2015
)
0.96
" Safety assessments included adverse events (AEs), laboratory tests, vital signs and local skin tolerability."( Clindamycin phosphate 1·2%-benzoyl peroxide 3·0% fixed-dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single-blinded, acti
Alió Sáenz, AB; Hashimoto, H; Kawashima, M; Ono, M; Yamada, M, 2015
)
0.71
" The incidence of adverse drug reactions was higher for CLNP/BPO 3·0% once (24·0%) or twice (35·1%) daily than for CLNP twice daily (9·0%)."( Clindamycin phosphate 1·2%-benzoyl peroxide 3·0% fixed-dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single-blinded, acti
Alió Sáenz, AB; Hashimoto, H; Kawashima, M; Ono, M; Yamada, M, 2015
)
0.71
" All adverse events were mild or moderate."( Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in Japanese patients? A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study.
Alio Sáenz, AB; Hashimoto, H; Kawashima, M; Ono, M; Yamada, M, 2014
)
1.02
" No serious adverse events were reported."( Safety and efficacy of adapalene 0.1% / benzoyl peroxide 2.5% in the long-term treatment of predominantly moderate acne with or without concomitant medication - results from the non-interventional cohort study ELANG.
Friedrich, M; Gollnick, HP; Jäckel, A; Jöstingmeyer, P; Peschen, M; Pettker, R; Pier, A; Porombka, D; Rojo Pulido, I; Streit, V, 2015
)
0.68
"In consistence with previous clinical findings, the use of adapalene-BPO in daily practice routine is safe and effective in the long-term management of patients with moderate to severe acne."( Safety and efficacy of adapalene 0.1% / benzoyl peroxide 2.5% in the long-term treatment of predominantly moderate acne with or without concomitant medication - results from the non-interventional cohort study ELANG.
Friedrich, M; Gollnick, HP; Jäckel, A; Jöstingmeyer, P; Peschen, M; Pettker, R; Pier, A; Porombka, D; Rojo Pulido, I; Streit, V, 2015
)
0.68
" Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values."( Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.
Katsuramaki, T; Kawashima, M; Nagare, T, 2017
)
0.68
" Safety assessment also showed that the incidence of adverse events was higher in Japanese patients than in Western patients, but the characteristics of the adverse events were not different."( Clinical efficacy and safety of benzoyl peroxide for acne vulgaris: Comparison between Japanese and Western patients.
Doi, M; Kawashima, M; Nagare, T, 2017
)
0.74
" Safety assessments included adverse events (AEs) and tolerability."( Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin.
Baldwin, H; Del Rosso, JQ; Johnson, SM; Lain, EL; Landis, M; Rendon, M; Rueda, MJ; Stein Gold, L; Tanghetti, E; Weiss, J, 2018
)
0.75
"3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used."( Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin.
Baldwin, H; Del Rosso, JQ; Johnson, SM; Lain, EL; Landis, M; Rendon, M; Rueda, MJ; Stein Gold, L; Tanghetti, E; Weiss, J, 2018
)
0.75
" No untoward adverse events, visible irritation, or significant flare-up were observed."( Safety and Efficacy of Topically Applied Selected Cutibacterium acnes Strains over Five Weeks in Patients with Acne Vulgaris: An Open-label, Pilot Study.
Brüggemann, H; Gollnick, H; Güell, M; Karoglan, A; Paetzold, B; Pereira de Lima, J; Schanze, D; Tüting, T, 2019
)
0.51
"The most common adverse event of epidermal growth factor receptor inhibitors, used to treat colorectal, non-small cell lung, and head and neck cancers, is acneiform eruption, with a profound effect on treatment continuation."( Efficacy and safety of topical benzoyl peroxide for prolonged acneiform eruptions induced by cetuximab and panitumumab: A multicenter, phase II trial.
Aiba, S; Kikuchi, K; Namikawa, K; Nozawa, K; Takashima, A; Tsuchiyama, K; Tsutsui, K; Yamazaki, N, 2021
)
0.91
" The standard treatment involves topical and oral antibiotics, retinoids, benzoyl peroxide, and other synthetic compounds, mostly associated with adverse effects."( Clinical study to assess efficacy and safety of Purifying Neem Face Wash in prevention and reduction of acne in healthy adults.
Gajjar, T; Kumawat, R; Patel, N; Rajaiah Yogesh, H, 2022
)
0.95
" Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed."( Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug.
Baldwin, H; Beer, K; Bhatt, V; Callender, V; Draelos, Z; Gold, M; Kircik, LH; Lain, E; Pariser, DM; Pillai, R; Sadick, N; Stein Gold, L; Tanghetti, EA; Weiss, JS, 2022
)
0.96
" IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity."( Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug.
Baldwin, H; Beer, K; Bhatt, V; Callender, V; Draelos, Z; Gold, M; Kircik, LH; Lain, E; Pariser, DM; Pillai, R; Sadick, N; Stein Gold, L; Tanghetti, EA; Weiss, JS, 2022
)
0.96

Compound-Compound Interactions

Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris. Five days a week, the three materials were applied in a nonocclusive manner.

ExcerptReferenceRelevance
" Five days a week, the three materials (benzoyl peroxide, clindamycin phosphate, and erythromycin) were applied in a nonocclusive manner either alone or in combination with adapalene gel on seven cutaneous sites on the upper back."( Skin tolerance of adapalene 0.1% gel in combination with other topical antiacne treatments.
Caron, D; Clucas, A; Sorba, V; Verschoore, M, 1997
)
0.56
"By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions."( Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer for the treatment of acne vulgaris: a 12-week, randomized, double-blind study.
Abramovits, W; Eichenfield, LF; Fleischer, AB; Garrett, S; Lucky, A; Shalita, A, 2010
)
0.61
"Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris."( Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer for the treatment of acne vulgaris: a 12-week, randomized, double-blind study.
Abramovits, W; Eichenfield, LF; Fleischer, AB; Garrett, S; Lucky, A; Shalita, A, 2010
)
0.86
" The objective of this experimental study was to determine the wear of tibial polyethylene inserts combined with metallic and ceramic femoral components under third-body wear conditions initiated by bone cement particles."( Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study.
Bader, R; Bergschmidt, P; Lange, R; Mittelmeier, W; Zietz, C, 2013
)
0.39
" Tibial polyethylene inserts were combined with the identical femoral component design, but made of two different materials (cobalt-chromium and ceramic)."( Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study.
Bader, R; Bergschmidt, P; Lange, R; Mittelmeier, W; Zietz, C, 2013
)
0.39
"The average gravimetrical wear of the tibial polyethylene inserts in combination with 
cobalt-chromium and ceramic femoral components under third-body wear conditions amounted to 31."( Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study.
Bader, R; Bergschmidt, P; Lange, R; Mittelmeier, W; Zietz, C, 2013
)
0.39
"The wear simulator test demonstrates that wear of polyethylene inserts under third-body wear conditions, in combination with ceramic femoral components, was significantly lower than with metallic femoral components."( Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study.
Bader, R; Bergschmidt, P; Lange, R; Mittelmeier, W; Zietz, C, 2013
)
0.39
"2% (T/CP) gel in combination with a benzoyl peroxide 6% foaming cloth compared with T/CP alone for facial acne."( Efficacy and safety of tretinoin 0.025%/clindamycin phosphate 1.2% gel in combination with benzoyl peroxide 6% cleansing cloths for the treatment of facial acne vulgaris.
Haddican, M; Linkner, RV; Wong, V; Zeichner, JA, 2013
)
0.89
"In conclusion, the tested skincare combined with a fixed adapalene and benzoyl peroxide combination provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne."( A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne.
Bouloc, A; Chadoutaud, B; Dréno, B; Imko-Walczuk, B; Moga, A; Roo, E, 2017
)
0.94

Bioavailability

ExcerptReferenceRelevance
" These results are interpreted in terms of bioavailability of the active substances."( Imidazoles and benzoyl peroxide: a comparative trial of two treatment schedules.
Decroix, J; Tennstedt, D; Van Neste, D, 1986
)
0.62
" A solubilized formulation of BPO has been developed to maximize its bioavailability and enhance follicular penetration."( Solubilized benzoyl peroxide versus benzoyl peroxide/clindamycin in the treatment of moderate acne.
Dhawan, S; Kircik, L; Tanghetti, E; Wilson, D, 2008
)
0.72
"A 3-step acne system has been developed to enhance the bioavailability and follicular penetration of benzoyl peroxide (BPO)."( A 3-step acne system containing solubilized benzoyl peroxide versus clindamycin-benzoyl peroxide.
Del Rosso, JQ; Eichenfield, L; Parr, L; Shalita, A; Swinyer, L; Tanghetti, E; Thiboutot, D; Tschen, E, 2009
)
0.83
" Significantly enhanced dermal bioavailability (AD-2."( Codelivery of benzoyl peroxide & adapalene using modified liposomal gel for improved acne therapy.
Jain, S; Kale, DP; Katiyar, SS; Swami, R, 2018
)
0.84
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" Those drug-delivery forms offer convenient self-administration; obviate gastrointestinal-tract absorption and hepatic-first-pass metabolism, thereby improving bioavailability and maintaining sufficient drug concentration within the therapeutic window; and facilitate the transmission of the largest fraction of drug molecules to the target area, thus maximizing therapeutic potential and reducing systemic drug toxicity."( A Compendium of Compounding Agents and Formulations, Part 3: Gentamicin Sulfate and Benzoyl Peroxide.
Riepl, M,
)
0.36

Dosage Studied

The appropriate dosage and duration of topical benzoyl peroxide gel (BP) treatment of pitted keratolysis (PK) is controversial. A selective high-performance liquid chromatographic (HPLC) procedure for the quantitative determination in pharmaceutical dosage forms is described.

ExcerptRelevanceReference
" The number of colonies which developed during promoter exposure in cocultures showed a dose-response curve which differed from the dose-response curve for stimulation of growth of 308 colonies in the absence of normal keratinocytes."( Development of an in vitro analogue of initiated mouse epidermis to study tumor promoters and antipromoters.
Hennings, H; Jung, R; Michael, DM; Pettit, GR; Robinson, VA; Yuspa, SH, 1990
)
0.28
" Additionally, on this dosing regimen, the peak of ODC activity shifted to approximately 4 h after the last treatment, so that the time-course of ODC induction resembled that after multiple applications of TPA."( Characterization of the induction of ornithine decarboxylase activity by benzoyl peroxide in SENCAR mouse epidermis.
Binder, RL; Motz, AA; Volpenhein, ME, 1989
)
0.51
" The relapse rate on stopping antibiotics is also significantly less in patients given I g daily and this dosage did not produce any increase in side effects."( Evaluation of a therapeutic strategy for the treatment of acne vulgaris with conventional therapy.
Burke, B; Cunliffe, WJ; Greenwood, R, 1986
)
0.27
" Doubling of erythromycine dosage could not prevent premenstrual exacerbation of acne."( On therapeutic approaches to some special types of acne.
Rajka, G, 1985
)
0.27
" Significantly, studies in this laboratory indicated that B6C3F1 mice dosed with BZP demonstrated increased NK activity in the spleen as was observed after dosing with TPA."( Modulation of natural killer activity by 12-O-tetradecanoylphorbol-13-acetate and benzoyl peroxide in phorbol ester-sensitive (SENCAR) and resistant (B6C3F1) mice.
Chuthaputti, A; Pfeifer, RW; Updyke, LW; Yim, GK, 1988
)
0.5
"A selective high-performance liquid chromatographic (HPLC) procedure for the quantitative determination of benzoyl peroxide in pharmaceutical dosage forms is described."( Quantitative determination of benzoyl peroxide by high-performance liquid chromatography and comparison to the iodometric method.
Anthony, G; Gaddipati, N; Volpe, F, 1983
)
0.77
" In addition, their in vitro profiles suggest the potential for combination use, affording greater dosing flexibility."( Optimizing topical combination therapy for the treatment of acne vulgaris.
Zeichner, JA, 2012
)
0.38
"Encapsulation of more than one active pharmaceutical ingredient into nanocarriers such as liposomes is an attractive approach to achieve a synergic drug effect and less complicated dosing schedules in multi-drug treatment regimes."( Successful co-encapsulation of benzoyl peroxide and chloramphenicol in liposomes by a novel manufacturing method - dual asymmetric centrifugation.
de Albuquerque Cavalcanti Jacobsen, C; Holsæter, AM; Ingebrigtsen, SG; Škalko-Basnet, N, 2017
)
0.74
"The appropriate dosage and duration of topical benzoyl peroxide gel (BP) treatment of pitted keratolysis (PK) is controversial."( Randomized, controlled trial testing the effectiveness and safety of 2.5% and 5% benzoyl peroxide for the treatment of pitted keratolysis.
Bunyaratavej, S; Kiratiwongwan, R; Leeyaphan, C; Limphoka, P; Ongsri, P, 2021
)
1.1
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (56 Product(s))

Product Categories

Product CategoryProducts
Other40
Produits de la mer, Poissons et dérivés, Poissons, Poissons maigres, Filets de poissons, Morues, Filets de cabillaud1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Matières grasses, Matières grasses végétales, Produits de l'olivier, Huiles, Huiles d'olive, Huiles d'olive vierges extra, Huiles d'olive vierges1
Meats and their products, Meats, Pork and its products, Pork, Bacon, Sliced bacon1
Seafood,Mollusc,Oysters,fr:Huîtres fines1
Snacks, Snacks sucrés, Barres, Barres de céréales, Barres de céréales au chocolat1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Fruits à coques et dérivés, Fruits à coques, Fruits à coques décortiqués, Noix, Cerneaux de noix1
Viandes et dérivés, Viande de bœuf et dérivés, Viandes, Bœuf, Préparations de viande1
Aliments et boissons à base de végétaux, Aliments d'origine végétale, Céréales et pommes de terre, Céréales et dérivés, Produits déshydratés, Pâtes alimentaires, Produits lyophilisés à reconstituer, Nouilles, Nouilles instantanées1
Aliments et boissons à base de végétaux, Boissons, Boissons chaudes, Boissons à base de végétaux, Thés1
Produits d'élevages, Œufs, Œufs frais1
Snacks, Snacks sucrés, Cacao et dérivés, Chocolats1
Aliments et boissons à base de végétaux,Aliments d'origine végétale,Aliments à base de fruits et de légumes,Surgelés,Fruits et produits dérivés,Aliments à base de plantes surgelés,Fruits,Fruits surgelés,Cerises,Griottes,Cerises surgelées1
Produits de la mer, Poissons et dérivés, Poissons, Poissons gras, Sardines1
Snacks, Snacks sucrés, Cacao et dérivés, Confiseries, Confiseries chocolatées1
Plant-based foods and beverages, Plant-based foods, Fruits and vegetables based foods, Meals, Soups, Cream soups, Vegetable soups, Cream of vegetable soups, Cream of asparagus soups1
Seafood, Canned foods, Fishes, Fatty fishes, Canned fishes, Tunas, Canned tunas1

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
Solid white albacore tuna in waterStarkistSeafood, Canned foods, Fishes, Fatty fishes, Canned fishes, Tunas, Canned tunaspyrophosphate2024-02-09

Drug Classes (1)

ClassDescription
carbonyl compoundAny compound containing the carbonyl group, C=O. The term is commonly used in the restricted sense of aldehydes and ketones, although it actually includes carboxylic acids and derivatives.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (4)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
acetylcholinesteraseHomo sapiens (human)Potency3.89020.002541.796015,848.9004AID1347395
thyroid hormone receptor beta isoform aHomo sapiens (human)Potency0.15850.010039.53711,122.0200AID588547
lamin isoform A-delta10Homo sapiens (human)Potency0.00630.891312.067628.1838AID1487
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency25.11890.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Ceullar Components (1)

Processvia Protein(s)Taxonomy
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (51)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,099)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990292 (26.57)18.7374
1990's151 (13.74)18.2507
2000's290 (26.39)29.6817
2010's283 (25.75)24.3611
2020's83 (7.55)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 72.42

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index72.42 (24.57)
Research Supply Index7.28 (2.92)
Research Growth Index4.62 (4.65)
Search Engine Demand Index247.68 (26.88)
Search Engine Supply Index3.83 (0.95)

This Compound (72.42)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials255 (21.45%)5.53%
Reviews186 (15.64%)6.00%
Case Studies77 (6.48%)4.05%
Observational4 (0.34%)0.25%
Other667 (56.10%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (113)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne [NCT01220102]3,113 participants (Actual)Observational2010-05-31Completed
A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients [NCT05096312]Phase 423 participants (Actual)Interventional2018-12-21Completed
Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction [NCT04362488]23 participants (Actual)Interventional2019-02-04Completed
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris [NCT01044264]602 participants (Actual)Interventional2007-12-31Completed
A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin [NCT01206348]Phase 497 participants (Actual)Interventional2010-09-30Completed
Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation [NCT04021524]Phase 450 participants (Actual)Interventional2018-09-10Completed
A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) i [NCT01132443]Phase 172 participants (Actual)Interventional2010-05-06Completed
Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel [NCT03122457]Phase 222 participants (Actual)Interventional2017-01-01Completed
Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics [NCT02099240]Early Phase 111 participants (Actual)Interventional2014-03-06Terminated(stopped due to Not enough patient enrollment and lack of staffing)
Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne [NCT03076320]Phase 1/Phase 282 participants (Actual)Interventional2017-03-27Completed
The Use of Oracea and Epiduo Forte in Severe Acne Patients [NCT03457636]Phase 422 participants (Actual)Interventional2018-03-19Completed
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris [NCT03761784]Phase 3424 participants (Actual)Interventional2018-12-21Completed
A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne Vulgaris [NCT02698436]103 participants (Actual)Interventional2016-03-31Completed
The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne [NCT03650881]0 participants (Actual)Interventional2018-08-07Withdrawn(stopped due to no eligible subjects were enrolled)
Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne [NCT02338544]1,388 participants (Actual)Observational2015-01-31Completed
Efficacy of Combination of Topical Benzoyl Peroxide and Electrocautery Skin Incision in Eradicating Cutibacterium Acnes From Surgical Wounds During Shoulder Arthroplasty [NCT05676411]Phase 470 participants (Anticipated)Interventional2024-06-01Not yet recruiting
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris [NCT03761810]Phase 3434 participants (Actual)Interventional2018-12-14Completed
Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties [NCT05675501]Phase 131 participants (Actual)Interventional2020-06-10Completed
Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum. [NCT05536882]Phase 3150 participants (Anticipated)Interventional2023-02-28Not yet recruiting
Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples) [NCT01260571]Phase 462 participants (Anticipated)Interventional2011-01-31Not yet recruiting
A Multi-Center, Double Blind, Vehicle Controlled, Study of Retin-A Micro 0.04% in the Treatment of Pediatric Acne Vulgaris in Children, Ages 9 to 11 Years of Age [NCT00907335]Phase 2110 participants (Actual)Interventional2009-02-28Completed
A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris [NCT01016977]Phase 440 participants (Actual)Interventional2009-10-31Completed
A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris [NCT02595034]Phase 11,000 participants (Actual)Interventional2015-01-31Completed
A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris [NCT00671749]Phase 4100 participants (Actual)Interventional2007-12-31Completed
Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne [NCT00837213]Phase 433 participants (Actual)Interventional2007-08-31Completed
A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris [NCT00887484]Phase 450 participants (Actual)Interventional2009-02-28Completed
A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris. [NCT00964223]Phase 428 participants (Actual)Interventional2009-07-31Completed
A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream With Resveratrol , Replenix Power of Three Cream With Resveratrol With Adapalene and Benzoyl Peroxid [NCT03563365]Phase 443 participants (Actual)Interventional2018-06-04Terminated(stopped due to Lack of Funding)
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients [NCT04028401]Phase 3110 participants (Anticipated)Interventional2020-06-19Recruiting
Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris [NCT02616614]Phase 3862 participants (Actual)Interventional2015-05-31Completed
An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products (Retin-A Micro Gel, 0.04% Pump and Epiduo Gel) Using a Split-Face Model [NCT00952523]Phase 4162 participants (Actual)Interventional2009-07-31Completed
Efficacy of Blue Light Therapy in Reducing Cutibacterium Acnes Bioburden at the Deltopectoral Interval [NCT04300010]Phase 460 participants (Actual)Interventional2020-10-05Completed
A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris [NCT00776919]Phase 31,315 participants (Actual)Interventional2008-10-31Completed
A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris [NCT02709902]Phase 1460 participants (Actual)Interventional2015-09-30Completed
A Prospective Multi-Center Blinded, Randomized, Controlled Clinical Trial Comparing the Efficacy of Provodine Topical Body Wash Versus 10% Benzoyl Peroxide Topical Body Wash for the Treatment of Hidradenitis Suppurativa [NCT01818167]25 participants (Actual)Interventional2013-01-05Completed
[NCT00664248]Phase 31,414 participants (Actual)Interventional2006-10-31Completed
A Monocentric, Single-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of the Topical Drug Acnase Creme in the Treatment of Acne Vulgaris I and II [NCT00877409]Phase 380 participants (Anticipated)Interventional2009-04-30Not yet recruiting
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjec [NCT00421993]Phase 31,670 participants (Actual)Interventional2006-10-31Completed
National Clinical Trial, Phase III, Monocentric, Randomized, Open, Controlled, Parallel Study to Assess the Non-inferiority of Dalap Duo® Product (0,1% Adapalene and 2,5% Benzoyl Peroxide Gel Cream) Compared to Epiduo® (0,1% Adapalene and 2,5% Benzoyl Per [NCT02716090]Phase 30 participants (Actual)InterventionalWithdrawn(stopped due to Due to budget limitations, the company decided to withdraw this study.)
Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications [NCT00926367]Phase 452 participants (Actual)Interventional2009-05-31Completed
Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications [NCT01015638]Phase 436 participants (Actual)Interventional2009-08-31Completed
[NCT00663286]Phase 31,399 participants (Actual)Interventional2006-10-31Completed
A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris [NCT00713609]Phase 2591 participants (Actual)Interventional2008-06-30Completed
A Double Blind Randomised Comparison of Nadifloxacin 1% Cream Alone and Nadifloxacine %1 Cream With Benzoyl Peroxide 5% Solution in the Treatment of Mild to Moderate Facial Acne Vulgaris [NCT00869492]Phase 390 participants (Anticipated)Interventional2008-08-31Active, not recruiting
A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris [NCT02578043]Phase 1844 participants (Actual)Interventional2015-04-30Completed
Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study [NCT05355844]200 participants (Anticipated)Interventional2022-05-31Not yet recruiting
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris [NCT05629468]Phase 375 participants (Actual)Interventional2021-10-15Completed
A Phase 3, Randomized, Double-blind, Multi-dose Study to Evaluate the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG 5%) When Co-administered With Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4% in the Treatment of Acne Vulgaris. [NCT00151541]Phase 3301 participants (Actual)Interventional2005-02-28Completed
Evaluation of the Efficacy and Tolerance of Formula 609613 37 in Acneic Patients as an Adjunct to and in Addition to 5% Benzoyl Peroxide for 6 Months [NCT05469880]100 participants (Actual)Interventional2009-10-21Completed
The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial [NCT01052246]80 participants (Actual)Interventional2008-10-31Completed
A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L [NCT01501799]885 participants (Actual)Interventional2011-07-31Completed
Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Clindamycin and Benzoyl Peroxide to Dapsone Gel Topical Acne Medications [NCT00964366]Phase 453 participants (Actual)Interventional2009-07-31Completed
Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Doxycycline in Severe Inflammatory Acne (Non-Nodulocystic) Subjects [NCT02899000]Phase 4186 participants (Actual)Interventional2016-07-29Completed
A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morni [NCT00907257]Phase 4247 participants (Actual)Interventional2009-02-28Completed
A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment o [NCT01422785]Phase 440 participants (Anticipated)Interventional2011-07-31Recruiting
Dermal Safety Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) With Healthy Japanese Male and Female Subjects [NCT01428466]Phase 120 participants (Actual)Interventional2010-11-18Completed
"A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients." [NCT05855629]59 participants (Actual)Interventional2022-02-18Active, not recruiting
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris [NCT01209949]Phase 430 participants (Actual)Interventional2010-10-31Completed
Triple Prevention Against Cutibacterium Acnes Using Benzoyl Peroxide Preparation in Addition to Pre-operative Cutaneous and Subcutaneous Iodine in Shoulder Surgery; a Single-blinded, Randomized, Controlled Trial. [NCT05701475]156 participants (Anticipated)Interventional2023-02-28Not yet recruiting
Randomized Study Comparing the Efficacy and Tolerance of a Lipophilic Hydroxy Acid Derivative of Salicylic Acid and 5% Benzoyl Peroxide in the Treatment of Facial Acne Vulgaris [NCT00624676]80 participants (Actual)Interventional2006-01-31Completed
An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using A Split-Face Model [NCT00919191]Phase 426 participants (Actual)Interventional2009-04-30Completed
Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide [NCT03257202]Phase 212 participants (Actual)Interventional2017-09-11Completed
A Randomized Split-Face Controlled Trial Comparing Efficacy of 2940 Nanometer Er:YAG Laser to 2.5% BP Gel for the Treatment of Inflammatory Acne [NCT01472900]25 participants (Anticipated)Interventional2010-10-31Completed
A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris [NCT00446043]Phase 3452 participants (Actual)Interventional2004-02-17Completed
A Split-face, Paired-comparison Pilot Study to Evaluate the Safety and Efficacy of Topical Benzoyl Peroxide 2.5% Cream Alone Versus Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion for Mild to Moderate Acne Vulgaris [NCT00558831]11 participants (Actual)Interventional2007-10-31Completed
A Split-face, Paired-comparison, Pilot Study to Evaluate Safety and Efficacy of Two Topical Benzoyl Peroxide 10.0% Creams for Mild to Moderate Acne Vulgaris [NCT00787943]10 participants (Actual)Interventional2008-05-31Completed
A Long Term Study of GK530G in Subjects With Acne Vulgaris [NCT01910064]Phase 3436 participants (Actual)Interventional2013-05-31Completed
Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication [NCT01618773]6,036 participants (Actual)Observational2012-06-30Completed
Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne [NCT00658112]Phase 420 participants (Actual)Interventional2006-07-31Completed
Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery [NCT03573115]16 participants (Actual)Interventional2018-01-04Completed
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) to Epiduo® (Galderma Laboratories, L.P., Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) an [NCT01742637]Phase 12,008 participants (Actual)Interventional2012-10-31Completed
A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Ge [NCT01769235]Phase 11,215 participants (Actual)Interventional2012-11-30Completed
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of [NCT01769664]Phase 1650 participants (Actual)Interventional2012-09-30Completed
A Multicenter, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel and Acanya® 1.2%/2.5% and Both Active Treatments to Vehicle Control for Treating Acne Vulgaris [NCT01788384]Phase 3708 participants (Actual)Interventional2012-07-31Completed
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active [NCT01138514]Phase 31,555 participants (Actual)Interventional2009-10-31Completed
[NCT02515305]Phase 3890 participants (Actual)Interventional2015-07-31Completed
[NCT01231334]Phase 4286 participants (Actual)Interventional2010-08-31Completed
A Pilot Study to Evaluate the Safety and Tolerability of CeraVe® Lotion Followed by Fixed Dose Clindamycin Phosphate 1.2% / Benzoyl Peroxide 2.5% Gel in the Morning in Combination With CeraVe® Lotion Followed by Tretinoin 0.05% Gel in the Evening for the [NCT01448733]Phase 420 participants (Actual)Interventional2011-07-31Active, not recruiting
A Novel Method for Improving Acne Outcomes [NCT01176955]20 participants (Actual)Interventional2009-05-31Completed
A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris [NCT01138735]Phase 4285 participants (Actual)Interventional2010-06-30Completed
Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne [NCT01106807]Phase 273 participants (Actual)Interventional2010-04-30Completed
A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris [NCT01677221]30 participants (Actual)Interventional2012-07-31Completed
Efficacy of a Handheld Heat Based Device for the Spot Treatment of Mild to Moderate Acne Vulgaris: A Controlled Study to Determine Time to Resolution of Individual Inflammatory Lesions Using an Over-the-counter Acne Heat Device. [NCT01613924]Phase 40 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to Lack of funding and resources)
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd. Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel (Clindamycin Phosphate and Benzoyl P [NCT01796665]Phase 31,180 participants (Actual)Interventional2012-02-29Completed
[NCT02525549]Phase 3903 participants (Actual)Interventional2011-12-31Completed
A Randomized, Double-blinded Study to Evaluate the Ability of an Acne Treatment Product to Produce Visible Improvements in Acne Lesions Over a 5 Day Period of Once-daily Use [NCT02052752]Phase 490 participants (Actual)Interventional2014-02-28Completed
Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection [NCT02510144]80 participants (Actual)Interventional2015-08-31Completed
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjec [NCT00422240]Phase 31,656 participants (Anticipated)Interventional2006-06-30Completed
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris [NCT03393494]Phase 3825 participants (Actual)Interventional2017-12-13Completed
[NCT00377000]Phase 460 participants Interventional2005-11-30Completed
A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris. [NCT02073461]Phase 2236 participants (Actual)Interventional2014-03-31Completed
Benzaknen® 5% Gel in Combination With Dermotivin® Soft Liquid Soap and Non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the Treatment of Mild-to-moderate Acne Vulgaris [NCT02589405]Phase 450 participants (Actual)Interventional2015-08-31Completed
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty [NCT03849885]Phase 4496 participants (Anticipated)Interventional2019-02-02Recruiting
Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump, Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foam Wash Regimen in Student Athletes With Mild to Moderate Acne Vulgaris [NCT02249104]Phase 428 participants (Actual)Interventional2014-08-31Completed
Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery [NCT02219776]100 participants (Actual)Interventional2015-09-30Completed
An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne [NCT01446237]125 participants (Actual)Interventional2011-06-01Completed
A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor [NCT04000347]Phase 40 participants (Actual)Interventional2019-06-26Withdrawn(stopped due to Due to covid 19 outbreaks, the study are suspended.)
U0289-404: An Evaluator Blinded, 8 Week, Split Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITYII and MURAD in Subjects With Acne [NCT02524665]Phase 420 participants (Actual)Interventional2009-09-30Completed
Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment [NCT00687908]Phase 3243 participants (Actual)Interventional2008-11-30Completed
Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris [NCT01951417]Phase 481 participants (Actual)Interventional2013-10-31Completed
Study STF115288, a Clinical Confirmation Study of GI148512 (Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects.- A Multicenter, Randomized, Double-blinded, Vehicle-controlled, Parallel-group Study - [NCT01400932]Phase 3360 participants (Actual)Interventional2011-07-31Completed
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea [NCT03564119]Phase 3372 participants (Actual)Interventional2018-06-21Completed
A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC® [NCT02005666]Phase 3850 participants (Actual)Interventional2013-11-30Completed
Evaluation of the Effectiveness of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) in Reducing Antibiotic Sensitive and Resistant Strains of P Acnes [NCT00907101]Phase 430 participants (Actual)Interventional2009-06-30Completed
Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications [NCT05582434]Early Phase 172 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Profiling the Skin Microbiome in Response to Altreno in Acne Patients [NCT04548349]Phase 437 participants (Actual)Interventional2021-04-23Completed
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea [NCT03448939]Phase 3361 participants (Actual)Interventional2018-06-18Completed
A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients [NCT03564145]Phase 3547 participants (Actual)Interventional2018-09-12Terminated(stopped due to Per protocol, the Sponsor could terminate the study once 300 participants completed a total of 28 weeks of treatment and 100 participants completed a total of 52 weeks.)
The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty; a Pilot Study [NCT04112407]120 participants (Actual)Interventional2019-01-10Completed
[NCT02651220]Phase 31,001 participants (Actual)Interventional2015-11-30Completed
A Multicenter, Randomized, Double-blinded, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris. [NCT02073448]Phase 3417 participants (Actual)Interventional2014-03-31Completed
Effect of Sample Medication Use and Application Instructions on Adherence to and Efficacy of Treatment of Patients With Mild to Moderate Acne With Epiduo(R) Gel [NCT01504204]Phase 420 participants (Actual)Interventional2011-12-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel [NCT02465632]Phase 31,100 participants (Actual)Interventional2015-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00421993 (6) [back to overview]Percent Change in Noniflammatory Lesion Counts
NCT00421993 (6) [back to overview]Percent Change in Total Lesion Counts
NCT00421993 (6) [back to overview]Success Rate on the Investigator's Global Assessment
NCT00421993 (6) [back to overview]Percent Change in Inflammatory Lesion Counts
NCT00421993 (6) [back to overview]Changes in Inflammatory Lesion Counts
NCT00421993 (6) [back to overview]Changes in Noninflammatory Lesion Counts
NCT00446043 (7) [back to overview]Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)
NCT00446043 (7) [back to overview]Number of Participants With Local Tolerability Assessment For Dryness
NCT00446043 (7) [back to overview]Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
NCT00446043 (7) [back to overview]Number of Participants With Clinically Significant Abnormal Laboratory Parameters
NCT00446043 (7) [back to overview]Number of Participants With Local Tolerability Assessment For Erythema
NCT00446043 (7) [back to overview]Number of Participants With Local Tolerability Assessment For Scaling
NCT00446043 (7) [back to overview]Number of Participants With Local Tolerability Assessment For Stinging/Burning
NCT00558831 (1) [back to overview]Subject Reported Change From Baseline Scale
NCT00658112 (1) [back to overview]Adherence
NCT00671749 (7) [back to overview]Worst Post Baseline Tolerability Assessment - Scaling
NCT00671749 (7) [back to overview]Worst Post Baseline Tolerability Assessment - Erythema
NCT00671749 (7) [back to overview]Worst Post Baseline Tolerability Assessment - Dryness
NCT00671749 (7) [back to overview]Worst Post Baseline Tolerability Assessment - Burning/Stinging
NCT00671749 (7) [back to overview]Percent Change From Baseline in Total Lesion Counts
NCT00671749 (7) [back to overview]Global Severity Assessment Success
NCT00671749 (7) [back to overview]Global Assessment of Improvement From Baseline
NCT00687908 (5) [back to overview]Investigator Global Assessment (IGA) Maintenance Success at Week 24
NCT00687908 (5) [back to overview]Maintenance Success for Non-inflammatory Lesions at Week 24
NCT00687908 (5) [back to overview]Percent of Subjects With Adverse Events
NCT00687908 (5) [back to overview]Maintenance Success for Total Lesions at Week 24
NCT00687908 (5) [back to overview]Maintenance Success for Inflamatory Lesions at Week 24
NCT00713609 (4) [back to overview]Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
NCT00713609 (4) [back to overview]Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
NCT00713609 (4) [back to overview]Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
NCT00713609 (4) [back to overview]Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
NCT00776919 (14) [back to overview]Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
NCT00776919 (14) [back to overview]Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
NCT00776919 (14) [back to overview]Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
NCT00776919 (14) [back to overview]Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
NCT00776919 (14) [back to overview]Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
NCT00776919 (14) [back to overview]Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
NCT00776919 (14) [back to overview]Mean Duration of Study Product Use
NCT00776919 (14) [back to overview]Mean Change From Baseline to Week 12 in Total Lesion Counts
NCT00776919 (14) [back to overview]Mean Change From Baseline to Week 12 in Temperature
NCT00776919 (14) [back to overview]Mean Change From Baseline to Week 12 in Pulse Rate
NCT00776919 (14) [back to overview]Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
NCT00776919 (14) [back to overview]Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
NCT00776919 (14) [back to overview]Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
NCT00776919 (14) [back to overview]Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
NCT00787943 (1) [back to overview]Number of Inflammatory Lesions (Papules and Pustules)
NCT00837213 (8) [back to overview]Percent Change in Total Acne Lesion Counts From Baseline to Week 16
NCT00837213 (8) [back to overview]Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
NCT00837213 (8) [back to overview]Change in Investigator Global Assessment (IGA)
NCT00837213 (8) [back to overview]Percentage of Particpants With IGA Score at Week 16
NCT00837213 (8) [back to overview]Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
NCT00837213 (8) [back to overview]Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
NCT00837213 (8) [back to overview]Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
NCT00837213 (8) [back to overview]Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
NCT00887484 (44) [back to overview]Erythema (Redness)
NCT00887484 (44) [back to overview]Inflammatory Acne Lesion Counts
NCT00887484 (44) [back to overview]Investigators Static Global Assessment
NCT00887484 (44) [back to overview]Quality of Life Questionnaire - Global Score
NCT00887484 (44) [back to overview]Quality of Life Questionnaire - Functional Domain
NCT00887484 (44) [back to overview]Quality of Life Questionnaire - Emotional Domain
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Compliance at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
NCT00887484 (44) [back to overview]Non-inflammatory Acne Lesion Counts
NCT00887484 (44) [back to overview]Irritant/Allergic Contact Dermatitis
NCT00887484 (44) [back to overview]Irritant/Allergic Contact Dermatitis
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
NCT00887484 (44) [back to overview]Total Acne Lesion Counts
NCT00887484 (44) [back to overview]Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
NCT00887484 (44) [back to overview]Skin Peeling
NCT00887484 (44) [back to overview]Skin Peeling
NCT00887484 (44) [back to overview]Skin Dryness
NCT00887484 (44) [back to overview]Skin Dryness
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
NCT00887484 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
NCT00887484 (44) [back to overview]Erythema (Redness)
NCT00907101 (5) [back to overview]Worst Post Baseline Tolerability Assessment - Stinging/Burning
NCT00907101 (5) [back to overview]Change From Baseline in Quantitative Bacteriology Measurements at Week 4
NCT00907101 (5) [back to overview]Worst Post Baseline Tolerability Assessment - Dryness
NCT00907101 (5) [back to overview]Worst Post Baseline Tolerability Assessment - Erythema
NCT00907101 (5) [back to overview]Worst Post Baseline Tolerability Assessment - Scaling
NCT00907257 (3) [back to overview]Measurement of Success
NCT00907257 (3) [back to overview]Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
NCT00907257 (3) [back to overview]Change From Baseline in Total Facial Acne Lesion Count
NCT00907335 (6) [back to overview]Change From Baseline in Total Non-inflammatory Lesion Count
NCT00907335 (6) [back to overview]Measurement of Success 2
NCT00907335 (6) [back to overview]Measurement of Success 3
NCT00907335 (6) [back to overview]Measurement of Success 1
NCT00907335 (6) [back to overview]Global Assessment
NCT00907335 (6) [back to overview]Change From Baseline in Lesion Counts
NCT00919191 (2) [back to overview]Self Assessment of Burning/Stinging and Itching
NCT00919191 (2) [back to overview]Comparative Assessment of Facial Irritation and Cutaneous Effects.
NCT00926367 (18) [back to overview]Skin Erythema (Redness)
NCT00926367 (18) [back to overview]Skin Dryness
NCT00926367 (18) [back to overview]Self Assessment of Texture (Roughness)
NCT00926367 (18) [back to overview]Self Assessment of Stinging
NCT00926367 (18) [back to overview]Self Assessment of Pain
NCT00926367 (18) [back to overview]Self Assessment of Oiliness
NCT00926367 (18) [back to overview]Self Assessment of Dryness
NCT00926367 (18) [back to overview]Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
NCT00926367 (18) [back to overview]Self Assessment of Crusting
NCT00926367 (18) [back to overview]Self Assessment of Burning
NCT00926367 (18) [back to overview]Self Assessment of Blistering
NCT00926367 (18) [back to overview]Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
NCT00926367 (18) [back to overview]Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
NCT00926367 (18) [back to overview]Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
NCT00926367 (18) [back to overview]Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
NCT00926367 (18) [back to overview]Skin Hydration
NCT00926367 (18) [back to overview]Skin Moisture and Hydration
NCT00926367 (18) [back to overview]Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
NCT00952523 (1) [back to overview]Facial Irritation and Cutaneous Effects
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Application of Product
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Burning
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Dryness
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Itching
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Redness
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Scaling
NCT00964223 (44) [back to overview]Erythema (Redness) Score
NCT00964223 (44) [back to overview]Erythema (Redness) Score
NCT00964223 (44) [back to overview]Inflammatory Acne Lesion Counts
NCT00964223 (44) [back to overview]Investigator Static Global Assessment Score
NCT00964223 (44) [back to overview]Irritant/Allergic Contact Dermatitis Score
NCT00964223 (44) [back to overview]Non-Inflammatory Acne Lesion Counts
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Comfort of Skin
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Compliance
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Compliance
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Application of Product
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Burning
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Dryness
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Itching
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Scaling
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
NCT00964223 (44) [back to overview]Skin Dryness Score
NCT00964223 (44) [back to overview]Skin Dryness Score
NCT00964223 (44) [back to overview]Skin Peeling Score
NCT00964223 (44) [back to overview]Skin Peeling Score
NCT00964223 (44) [back to overview]Skindex-29 Quality of Life Questionnaire - Emotional Domain
NCT00964223 (44) [back to overview]Skindex-29 Quality of Life Questionnaire - Functional Domain
NCT00964223 (44) [back to overview]Skindex-29 Quality of Life Questionnaire - Global Score
NCT00964223 (44) [back to overview]Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
NCT00964223 (44) [back to overview]Total Acne Lesion Counts
NCT00964223 (44) [back to overview]Irritant/Allergic Contact Dermatitis Score
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Severity of Redness
NCT00964223 (44) [back to overview]Product Acceptability and Preference Questionnaire - Comfort of Skin
NCT00964366 (5) [back to overview]Skin Erythema (Redness)
NCT00964366 (5) [back to overview]Skin Hydration
NCT00964366 (5) [back to overview]Transepidermal Water Loss (TEWL)
NCT00964366 (5) [back to overview]Skin Dryness
NCT00964366 (5) [back to overview]Sebum Measurements
NCT01015638 (12) [back to overview]Subject Assessment - Crusting
NCT01015638 (12) [back to overview]Subject Assessment - Dryness
NCT01015638 (12) [back to overview]Subject Assessment - Blistering
NCT01015638 (12) [back to overview]Changes in the Skin Surface Hydration
NCT01015638 (12) [back to overview]Erythema (Redness)
NCT01015638 (12) [back to overview]Skin Dryness
NCT01015638 (12) [back to overview]Skin Moisture and Hydration
NCT01015638 (12) [back to overview]Subject Assessment - Oiliness
NCT01015638 (12) [back to overview]Subject Assessment - Pain
NCT01015638 (12) [back to overview]Subject Assessment - Roughness
NCT01015638 (12) [back to overview]Subject Tolerability - Burning
NCT01015638 (12) [back to overview]Subject Tolerability - Stinging
NCT01016977 (15) [back to overview]Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
NCT01016977 (15) [back to overview]Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
NCT01016977 (15) [back to overview]Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
NCT01016977 (15) [back to overview]Overall Satisfaction With Study Product at Week 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12
NCT01016977 (15) [back to overview]Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12
NCT01044264 (1) [back to overview]Reduction of Inflammatory Lesions
NCT01138514 (3) [back to overview]Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
NCT01138514 (3) [back to overview]Percent Change From Baseline in Inflammatory Lesions
NCT01138514 (3) [back to overview]Percent Change From Baseline in Non-inflammatory Lesions
NCT01138735 (4) [back to overview]Change From Baseline in Total Lesion Counts
NCT01138735 (4) [back to overview]Change in Inflammatory Lesion Counts From Baseline
NCT01138735 (4) [back to overview]Percent Change in Total Lesion Counts From Baseline
NCT01138735 (4) [back to overview]Success Rate
NCT01176955 (4) [back to overview]The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.
NCT01176955 (4) [back to overview]The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.
NCT01176955 (4) [back to overview]The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
NCT01176955 (4) [back to overview]The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.
NCT01209949 (3) [back to overview]Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
NCT01209949 (3) [back to overview]Number of Participants With Tolerability Assessments Resulting in an Adverse Event
NCT01209949 (3) [back to overview]Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
NCT01231334 (7) [back to overview]Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
NCT01231334 (7) [back to overview]Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
NCT01231334 (7) [back to overview]Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
NCT01231334 (7) [back to overview]Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
NCT01231334 (7) [back to overview]Percent Change From Baseline in Total Lesion Count at Week 12
NCT01231334 (7) [back to overview]Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
NCT01231334 (7) [back to overview]Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
NCT01400932 (9) [back to overview]Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12
NCT01400932 (9) [back to overview]Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
NCT01400932 (9) [back to overview]Absolute Change in Total Lesion Counts From Baseline to Week 12
NCT01400932 (9) [back to overview]Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal
NCT01400932 (9) [back to overview]Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12
NCT01400932 (9) [back to overview]Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12
NCT01400932 (9) [back to overview]Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12
NCT01400932 (9) [back to overview]Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal
NCT01400932 (9) [back to overview]Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8
NCT01446237 (5) [back to overview]Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
NCT01446237 (5) [back to overview]Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
NCT01446237 (5) [back to overview]Mean Change in ISGA From Baseline to Each Study Visit
NCT01446237 (5) [back to overview]Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
NCT01446237 (5) [back to overview]Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
NCT01504204 (3) [back to overview]Change in Acne Global Assessment
NCT01504204 (3) [back to overview]Change in Acne Lesion Count
NCT01504204 (3) [back to overview]Adherence to Study Medication
NCT01796665 (3) [back to overview]Clinical Success on Investigator's Global Evaluation
NCT01796665 (3) [back to overview]Mean Percent Change in the Inflammatory (Papules and Pustules) Lesion Count
NCT01796665 (3) [back to overview]Mean Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Count
NCT01910064 (6) [back to overview]Local Tolerability (Stinging/Burning)
NCT01910064 (6) [back to overview]Local Tolerability (Dryness)
NCT01910064 (6) [back to overview]Local Tolerability (Erythema)
NCT01910064 (6) [back to overview]Local Tolerability (Pruritus)
NCT01910064 (6) [back to overview]Local Tolerability (Scaling)
NCT01910064 (6) [back to overview]Percent Changes From Baseline in Total Lesion Counts
NCT01951417 (8) [back to overview]Inflammatory Lesions
NCT01951417 (8) [back to overview]Scaling
NCT01951417 (8) [back to overview]Non-inflammatory Lesions
NCT01951417 (8) [back to overview]Subject Questionnaire
NCT01951417 (8) [back to overview]Stinging/Burning
NCT01951417 (8) [back to overview]Erythema
NCT01951417 (8) [back to overview]Dryness
NCT01951417 (8) [back to overview]Total Lesion Count
NCT02005666 (2) [back to overview]Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
NCT02005666 (2) [back to overview]Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
NCT02052752 (6) [back to overview]To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
NCT02052752 (6) [back to overview]To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
NCT02052752 (6) [back to overview]To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
NCT02052752 (6) [back to overview]To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
NCT02052752 (6) [back to overview]To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
NCT02052752 (6) [back to overview]To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.
NCT02073448 (7) [back to overview]Percent Changes From Baseline in Total Lesion Counts
NCT02073448 (7) [back to overview]Percent of Subjects With Adverse Events
NCT02073448 (7) [back to overview]Local Tolerability (Dryness)
NCT02073448 (7) [back to overview]Local Tolerability (Erythema)
NCT02073448 (7) [back to overview]Local Tolerability (Pruritus)
NCT02073448 (7) [back to overview]Local Tolerability (Scaling)
NCT02073448 (7) [back to overview]Local Tolerability (Stinging/Burning)
NCT02073461 (7) [back to overview]Local Tolerability (Dryness)
NCT02073461 (7) [back to overview]Percent Changes From Baseline in Total Lesion Counts
NCT02073461 (7) [back to overview]Local Tolerability (Erythema)
NCT02073461 (7) [back to overview]Percent of Subjects With Adverse Events
NCT02073461 (7) [back to overview]Local Tolerability (Stinging/Burning)
NCT02073461 (7) [back to overview]Local Tolerability (Scaling)
NCT02073461 (7) [back to overview]Local Tolerability (Pruritus)
NCT02249104 (6) [back to overview]Percent Change From Baseline in Non-inflammatory Lesion Count
NCT02249104 (6) [back to overview]Percent Change From Baseline in Inflammatory Lesion Count
NCT02249104 (6) [back to overview]Mean Change From Baseline in Total Lesion Count
NCT02249104 (6) [back to overview]Mean Change From Baseline in Non-inflammatory Lesion Count
NCT02249104 (6) [back to overview]Mean Change From Baseline in Inflammatory Lesion Count
NCT02249104 (6) [back to overview]Percent Change From Baseline in Total Lesion Count
NCT02465632 (2) [back to overview]Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
NCT02465632 (2) [back to overview]Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
NCT02510144 (2) [back to overview]Surgical Site Infection That Requires Antibiotics
NCT02510144 (2) [back to overview]Skin Swab and Culture With Colony Forming Units (CFUs)
NCT02515305 (2) [back to overview]Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions
NCT02515305 (2) [back to overview]Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions
NCT02524665 (6) [back to overview]Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
NCT02524665 (6) [back to overview]Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
NCT02524665 (6) [back to overview]Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
NCT02524665 (6) [back to overview]Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
NCT02524665 (6) [back to overview]Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
NCT02524665 (6) [back to overview]Percentage of Participant Who Improved by at Least One Grade on the ISGA
NCT02525549 (2) [back to overview]Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
NCT02525549 (2) [back to overview]Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
NCT02589405 (1) [back to overview]Number of Participants Satisfied and Very Satisfied With Regimen
NCT02616614 (3) [back to overview]Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
NCT02616614 (3) [back to overview]Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts
NCT02616614 (3) [back to overview]Number of Subjects With Treatment Success at Week 12
NCT02651220 (3) [back to overview]"Percentage of Patients With a Clinical Response of Clinical Success Using the Investigator's Global Assessment (IGA) at Week 12"
NCT02651220 (3) [back to overview]Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.
NCT02651220 (3) [back to overview]Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.
NCT02698436 (17) [back to overview]Investigator Global Acne Assessment - Week 1
NCT02698436 (17) [back to overview]Investigator Global Acne Assessment - Baseline
NCT02698436 (17) [back to overview]Acne Lesion Counts Total Global Face - Week 8
NCT02698436 (17) [back to overview]Acne Lesion Counts Total Global Face - Week 4
NCT02698436 (17) [back to overview]Acne Lesion Counts Total Global Face - Week 2
NCT02698436 (17) [back to overview]Acne Lesion Counts Total Global Face - Week 12
NCT02698436 (17) [back to overview]Acne Lesion Counts Total Global Face - Week 1
NCT02698436 (17) [back to overview]Acne Lesion Counts Total Global Face - Baseline
NCT02698436 (17) [back to overview]Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8
NCT02698436 (17) [back to overview]Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4
NCT02698436 (17) [back to overview]Investigator Global Acne Assessment - Week 12
NCT02698436 (17) [back to overview]Investigator Global Acne Assessment - Week 4
NCT02698436 (17) [back to overview]Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1
NCT02698436 (17) [back to overview]Percent Change of Global Face Total Acne Lesion Count From Baseline
NCT02698436 (17) [back to overview]Investigator Global Acne Assessment - Week 8
NCT02698436 (17) [back to overview]Investigator Global Acne Assessment - Week 2
NCT02698436 (17) [back to overview]Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2
NCT02899000 (11) [back to overview]Percent Change From Baseline in Non-Inflammatory Lesion Count
NCT02899000 (11) [back to overview]Percent Change From Baseline in Inflammatory Lesion Count
NCT02899000 (11) [back to overview]Number and Percent of Subjects With IGA Success
NCT02899000 (11) [back to overview]Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates
NCT02899000 (11) [back to overview]Change From Baseline in Total Lesion Count
NCT02899000 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Count
NCT02899000 (11) [back to overview]Change From Baseline in Inflammatory Lesion Count
NCT02899000 (11) [back to overview]Subject Assessment of Acne Improvement
NCT02899000 (11) [back to overview]Change in Number of Inflammatory Lesions
NCT02899000 (11) [back to overview]Number and Percent of Adverse Events
NCT02899000 (11) [back to overview]Percent Change From Baseline in Total Lesion Count
NCT03122457 (2) [back to overview]Adverse Event Severity
NCT03122457 (2) [back to overview]PGA Score
NCT03257202 (1) [back to overview]Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
NCT03393494 (2) [back to overview]Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
NCT03393494 (2) [back to overview]Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
NCT03448939 (3) [back to overview]Change From Baseline in Inflammatory Lesion Counts at Week 12
NCT03448939 (3) [back to overview]Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
NCT03448939 (3) [back to overview]Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
NCT03457636 (4) [back to overview]Non-inflammatory Lesion Count
NCT03457636 (4) [back to overview]IGA Score
NCT03457636 (4) [back to overview]Investigator Global Assessment (IGA) Score
NCT03457636 (4) [back to overview]Inflammatory Lesion Count
NCT03564119 (3) [back to overview]Change From Baseline in Inflammatory Lesion Counts at Week 12
NCT03564119 (3) [back to overview]Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
NCT03564119 (3) [back to overview]Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
NCT03564145 (1) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03761784 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
NCT03761784 (11) [back to overview]Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
NCT03761784 (11) [back to overview]Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
NCT03761784 (11) [back to overview]Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
NCT03761784 (11) [back to overview]Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
NCT03761784 (11) [back to overview]Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
NCT03761784 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
NCT03761784 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
NCT03761784 (11) [back to overview]Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
NCT03761784 (11) [back to overview]Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
NCT03761784 (11) [back to overview]Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
NCT03761810 (11) [back to overview]Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
NCT03761810 (11) [back to overview]Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
NCT03761810 (11) [back to overview]Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
NCT03761810 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
NCT03761810 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
NCT03761810 (11) [back to overview]Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
NCT03761810 (11) [back to overview]Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
NCT03761810 (11) [back to overview]Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
NCT03761810 (11) [back to overview]Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
NCT03761810 (11) [back to overview]Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
NCT03761810 (11) [back to overview]Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
NCT04021524 (2) [back to overview]Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate
NCT04021524 (2) [back to overview]Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate
NCT04300010 (4) [back to overview]Median Colony Forming Units Per mL Treatment vs Control
NCT04300010 (4) [back to overview]Percentage of Participants in Each Group With Positive C. Acnes Cultures
NCT04300010 (4) [back to overview]Median Colony Forming Units (CFU) After Treatment
NCT04300010 (4) [back to overview]Number of Participants With C. Acnes Bacterium Culture After Treatment
NCT05096312 (2) [back to overview]Inflammatory Score
NCT05096312 (2) [back to overview]Global Acne Grading System Score

Percent Change in Noniflammatory Lesion Counts

Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 (NCT00421993)
Timeframe: at week 12

InterventionPercent change (Mean)
Adapalene/Benzoyl Peroxide Gel-55.6
Adapalene Gel-46.0
Benzoyl Peroxide Gel-44.1
Gel Vehicle-32.3

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Percent Change in Total Lesion Counts

Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 (NCT00421993)
Timeframe: at week 12

InterventionPercent change (Mean)
Adapalene/Benzoyl Peroxide Gel-57.7
Adapalene Gel-47.5
Benzoyl Peroxide Gel-47.2
Gel Vehicle-35.2

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Success Rate on the Investigator's Global Assessment

"Percentage of subjects rated Clear and Almost Clear on 5-point scale (0=clear; 4=severe)" (NCT00421993)
Timeframe: at week 12

InterventionPercentage of participants (Number)
Adapalene/Benzoyl Peroxide Gel37.9
Adapalene Gel21.8
Benzoyl Peroxide Gel26.7
Gel Vehicle17.9

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Percent Change in Inflammatory Lesion Counts

Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 (NCT00421993)
Timeframe: at week 12

InterventionPercent change (Mean)
Adapalene/Benzoyl Peroxide Gel-61.7
Adapalene Gel-50.1
Benzoyl Peroxide Gel-52.2
Gel Vehicle-40.8

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Changes in Inflammatory Lesion Counts

Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts (NCT00421993)
Timeframe: from Baseline to week 12

InterventionLesion count (Median)
Adapalene/Benzoyl Peroxide Gel-18
Adapalene Gel-15
Benzoyl Peroxide Gel-16
Gel Vehicle-12

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Changes in Noninflammatory Lesion Counts

Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count (NCT00421993)
Timeframe: from Baseline to week 12

InterventionLesion count (Median)
Adapalene/Benzoyl Peroxide Gel-28
Adapalene Gel-24
Benzoyl Peroxide Gel-23
Gel Vehicle-18

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Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT00446043)
Timeframe: Baseline up to Month 14

InterventionParticipants (Count of Participants)
Participants (N) With At least one AEParticipants (N) With At Least one SAE
Adapalene/Benzoyl Peroxide2885

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Number of Participants With Local Tolerability Assessment For Dryness

"Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness)." (NCT00446043)
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

InterventionParticipants (Count of Participants)
Baseline72323857Week 172323857Week 272323857Month 172323857Month 272323857Month 472323857Month 672323857Month 872323857Month 1072323857Month 1272323857
1=Mild0=None2=Moderate3=Severe
Adapalene/Benzoyl Peroxide385
Adapalene/Benzoyl Peroxide65
Adapalene/Benzoyl Peroxide2
Adapalene/Benzoyl Peroxide195
Adapalene/Benzoyl Peroxide190
Adapalene/Benzoyl Peroxide35
Adapalene/Benzoyl Peroxide264
Adapalene/Benzoyl Peroxide152
Adapalene/Benzoyl Peroxide12
Adapalene/Benzoyl Peroxide1
Adapalene/Benzoyl Peroxide281
Adapalene/Benzoyl Peroxide121
Adapalene/Benzoyl Peroxide311
Adapalene/Benzoyl Peroxide109
Adapalene/Benzoyl Peroxide6
Adapalene/Benzoyl Peroxide337
Adapalene/Benzoyl Peroxide52
Adapalene/Benzoyl Peroxide320
Adapalene/Benzoyl Peroxide37
Adapalene/Benzoyl Peroxide4
Adapalene/Benzoyl Peroxide58
Adapalene/Benzoyl Peroxide278
Adapalene/Benzoyl Peroxide48
Adapalene/Benzoyl Peroxide3
Adapalene/Benzoyl Peroxide291
Adapalene/Benzoyl Peroxide36
Adapalene/Benzoyl Peroxide0

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Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF

Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF). (NCT00446043)
Timeframe: Baseline, Month 12 LOCF

Interventionpercent change (Mean)
Inflammatory Lesion CountsNoninflammatory Lesion CountsTotal Lesion Counts
Adapalene/Benzoyl Peroxide-59.70-58.80-58.85

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Number of Participants With Clinically Significant Abnormal Laboratory Parameters

Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. (NCT00446043)
Timeframe: Baseline up to Month 14

InterventionParticipants (Count of Participants)
HematologyBlood ChemistryUrine Analysis
Adapalene/Benzoyl Peroxide000

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Number of Participants With Local Tolerability Assessment For Erythema

"Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe." (NCT00446043)
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

InterventionParticipants (Count of Participants)
Baseline72323857Week 172323857Week 272323857Month 172323857Month 272323857Month 472323857Month 672323857Month 872323857Month 1072323857Month 1272323857
0 = None1 = Mild2=Moderate3=Severe
Adapalene/Benzoyl Peroxide348
Adapalene/Benzoyl Peroxide94
Adapalene/Benzoyl Peroxide10
Adapalene/Benzoyl Peroxide233
Adapalene/Benzoyl Peroxide157
Adapalene/Benzoyl Peroxide32
Adapalene/Benzoyl Peroxide1
Adapalene/Benzoyl Peroxide277
Adapalene/Benzoyl Peroxide133
Adapalene/Benzoyl Peroxide17
Adapalene/Benzoyl Peroxide2
Adapalene/Benzoyl Peroxide292
Adapalene/Benzoyl Peroxide105
Adapalene/Benzoyl Peroxide18
Adapalene/Benzoyl Peroxide320
Adapalene/Benzoyl Peroxide90
Adapalene/Benzoyl Peroxide16
Adapalene/Benzoyl Peroxide334
Adapalene/Benzoyl Peroxide48
Adapalene/Benzoyl Peroxide7
Adapalene/Benzoyl Peroxide296
Adapalene/Benzoyl Peroxide59
Adapalene/Benzoyl Peroxide6
Adapalene/Benzoyl Peroxide0
Adapalene/Benzoyl Peroxide276
Adapalene/Benzoyl Peroxide57
Adapalene/Benzoyl Peroxide8
Adapalene/Benzoyl Peroxide270
Adapalene/Benzoyl Peroxide56
Adapalene/Benzoyl Peroxide3
Adapalene/Benzoyl Peroxide284
Adapalene/Benzoyl Peroxide39
Adapalene/Benzoyl Peroxide4

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Number of Participants With Local Tolerability Assessment For Scaling

"Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a 0 (none) to 3 (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production)." (NCT00446043)
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

InterventionParticipants (Count of Participants)
Baseline72323857Week 172323857Week 272323857Month 172323857Month 272323857Month 472323857Month 672323857Month 872323857Month 1072323857Month 1272323857
0=None1=Mild2=Moderate3=Severe
Adapalene/Benzoyl Peroxide410
Adapalene/Benzoyl Peroxide41
Adapalene/Benzoyl Peroxide228
Adapalene/Benzoyl Peroxide164
Adapalene/Benzoyl Peroxide30
Adapalene/Benzoyl Peroxide1
Adapalene/Benzoyl Peroxide284
Adapalene/Benzoyl Peroxide130
Adapalene/Benzoyl Peroxide14
Adapalene/Benzoyl Peroxide312
Adapalene/Benzoyl Peroxide93
Adapalene/Benzoyl Peroxide10
Adapalene/Benzoyl Peroxide0
Adapalene/Benzoyl Peroxide338
Adapalene/Benzoyl Peroxide84
Adapalene/Benzoyl Peroxide4
Adapalene/Benzoyl Peroxide351
Adapalene/Benzoyl Peroxide330
Adapalene/Benzoyl Peroxide28
Adapalene/Benzoyl Peroxide3
Adapalene/Benzoyl Peroxide301
Adapalene/Benzoyl Peroxide38
Adapalene/Benzoyl Peroxide294
Adapalene/Benzoyl Peroxide33
Adapalene/Benzoyl Peroxide2
Adapalene/Benzoyl Peroxide308
Adapalene/Benzoyl Peroxide19

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Number of Participants With Local Tolerability Assessment For Stinging/Burning

"Local tolerability assessment for stinging/burning [prickling pain sensation immediately after (within 5 minutes of) dosing] was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort)." (NCT00446043)
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12

InterventionParticipants (Count of Participants)
Baseline72323857Week 172323857Week 272323857Month 172323857Month 272323857Month 472323857Month 672323857Month 872323857Month 1072323857Month 1272323857
2=Moderate3=Severe0=None1=Mild
Adapalene/Benzoyl Peroxide440
Adapalene/Benzoyl Peroxide10
Adapalene/Benzoyl Peroxide201
Adapalene/Benzoyl Peroxide154
Adapalene/Benzoyl Peroxide63
Adapalene/Benzoyl Peroxide319
Adapalene/Benzoyl Peroxide84
Adapalene/Benzoyl Peroxide21
Adapalene/Benzoyl Peroxide331
Adapalene/Benzoyl Peroxide66
Adapalene/Benzoyl Peroxide14
Adapalene/Benzoyl Peroxide373
Adapalene/Benzoyl Peroxide42
Adapalene/Benzoyl Peroxide364
Adapalene/Benzoyl Peroxide2
Adapalene/Benzoyl Peroxide0
Adapalene/Benzoyl Peroxide337
Adapalene/Benzoyl Peroxide20
Adapalene/Benzoyl Peroxide4
Adapalene/Benzoyl Peroxide312
Adapalene/Benzoyl Peroxide23
Adapalene/Benzoyl Peroxide5
Adapalene/Benzoyl Peroxide1
Adapalene/Benzoyl Peroxide303
Adapalene/Benzoyl Peroxide22
Adapalene/Benzoyl Peroxide306
Adapalene/Benzoyl Peroxide19

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Subject Reported Change From Baseline Scale

"-1=worse 0=unchanged~1=mild improvement~2=moderate improvement~3=clear" (NCT00558831)
Timeframe: baseline and 1 month

,
InterventionParticipants (Number)
-1=Worse0=Unchanged1=Mild Improvement2=Moderate Improvement3=Clear
Benzoyl Peroxide 2.5% Cream07111
Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion06121

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Adherence

Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied (NCT00658112)
Timeframe: 6 weeks

Interventionpercentage of doses actually applied (Mean)
Benzoyl Peroxide 5%46.5

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Worst Post Baseline Tolerability Assessment - Scaling

"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks

Interventionparticipants (Number)
NoneMildModerateSevere
Combination Therapy5327163

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Worst Post Baseline Tolerability Assessment - Erythema

"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks

Interventionparticipants (Number)
NoneMildModerateSevere
Combination Therapy2937330

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Worst Post Baseline Tolerability Assessment - Dryness

"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks

Interventionparticipants (Number)
NoneMildModerateSevere
Combination Therapy4927203

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Worst Post Baseline Tolerability Assessment - Burning/Stinging

"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks

Interventionparticipants (Number)
NoneMildModerateSevere
Combination Therapy671895

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Percent Change From Baseline in Total Lesion Counts

(NCT00671749)
Timeframe: 6 and 12 weeks

InterventionPercent Change (Mean)
Week 6Week 12
Combination Therapy-47-64

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Global Severity Assessment Success

Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear (NCT00671749)
Timeframe: 6 and 12 weeks

Interventionparticipants (Number)
Week 6Week 12
Combination Therapy842

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Global Assessment of Improvement From Baseline

(NCT00671749)
Timeframe: 12 weeks

Interventionparticipants (Number)
ClearAlmost ClearMarked ImprovementModerate ImprovementMinimal ImprovementNo ChangeWorse
Combination Therapy3402716581

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Investigator Global Assessment (IGA) Maintenance Success at Week 24

"IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.~IGA grade:~0 Clear:Residual hyperpigmentation & erythema may be present~Almost Clear:A few scattered comedones & a few small papules.~Mild:Some comedones & some papules and pustules. No nodules present~Moderate:Many comedones, papules & pustules. One nodule may be present~Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present~Very severe:Highly inflammatory acne covering the face; with nodules & cysts present" (NCT00687908)
Timeframe: Baseline, Week 24

Interventionpercent of subjects (Number)
Adapalene-BPO70.7
Vehicle34.2

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Maintenance Success for Non-inflammatory Lesions at Week 24

Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts. (NCT00687908)
Timeframe: Week 24

Interventionpercent of subjects (Number)
Adapalene-BPO78
Vehicle43.3

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Percent of Subjects With Adverse Events

All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent (NCT00687908)
Timeframe: Up to 24 weeks

Interventionpercent of subjects (Number)
Adapalene-BPO41.5
Vehicle29.2

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Maintenance Success for Total Lesions at Week 24

Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts. (NCT00687908)
Timeframe: Week 24

Interventionpercent of subjects (Number)
Adapalene-BPO78.9
Vehicle45.8

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Maintenance Success for Inflamatory Lesions at Week 24

Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts. (NCT00687908)
Timeframe: Week 24

Interventionpercent of subjects (Number)
Adapalene-BPO78
Vehicle48.3

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Proportion of Participants With an ISGA Score of 0 or 1 at Week 12

An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. (NCT00713609)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Benzoyl Peroxide/Clindamycin + Tazarotene33
Benzoyl Peroxide/Clindamycin + Vehicle Cream31
Benzoyl Peroxide Gel + Tazarotene27
Clindamycin Gel + Tazarotene39
Vehicle Gel + Tazarotene22
Vehicle Gel + Vehicle Cream13

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Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)

The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). (NCT00713609)
Timeframe: Baseline and up to Week 12

,,,,,
InterventionPercent change (Mean)
ILC, n=101, 103, 105, 105, 104, 52NILC, n=101, 103, 105, 105, 104, 52TLC, n=101, 103, 105, 105, 104, 52
Benzoyl Peroxide Gel + Tazarotene-62.4-60.6-62.0
Benzoyl Peroxide/Clindamycin + Tazarotene-58.3-58.0-59.1
Benzoyl Peroxide/Clindamycin + Vehicle Cream-62.4-39.2-47.9
Clindamycin Gel + Tazarotene-65.7-61.2-63.4
Vehicle Gel + Tazarotene-49.0-53.1-51.8
Vehicle Gel + Vehicle Cream-33.5-29.5-31.5

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Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. (NCT00713609)
Timeframe: Baseline and up to Week 12

InterventionPercentage of participants (Number)
Benzoyl Peroxide/Clindamycin + Tazarotene22
Benzoyl Peroxide/Clindamycin + Vehicle Cream22
Benzoyl Peroxide Gel + Tazarotene31
Clindamycin Gel + Tazarotene36
Vehicle Gel + Tazarotene20
Vehicle Gel + Vehicle Cream5

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Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12

The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). (NCT00713609)
Timeframe: Baseline and up to Week 12

,,,,,
InterventionLesion count (Mean)
ILC, n=101, 103, 105, 105, 104, 52NILC, n=101, 103, 105, 105, 104, 52TLC, n=101, 103, 105, 105, 104, 52
Benzoyl Peroxide Gel + Tazarotene-18.9-37.1-56.0
Benzoyl Peroxide/Clindamycin + Tazarotene-16.8-33.0-49.8
Benzoyl Peroxide/Clindamycin + Vehicle Cream-18.1-24.9-43.0
Clindamycin Gel + Tazarotene-18.8-37.5-56.3
Vehicle Gel + Tazarotene-14.5-33.0-47.6
Vehicle Gel + Vehicle Cream-8.96-18.9-27.8

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Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)

During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

,,,
InterventionPercent change in lesion counts (Mean)
Inflammatory LesionsNon-inflammatory LesionsTotal Lesions
BPO Gel-61.8-50.8-55.5
Clindamycin Gel-58.1-43.3-49.2
Duac Low-dose (LD) Gel-68.9-53.9-59.8
Vehicle Gel-48.8-34.0-40.4

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Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12

During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. (NCT00776919)
Timeframe: Week 12

Interventionparticipants (Number)
Duac Low-dose (LD) Gel148
Clindamycin Gel91
BPO Gel116
Vehicle Gel81

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Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging

Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline. (NCT00776919)
Timeframe: Baseline; Weeks 2, 4, 8, and 12

,,,
Interventionscores on a scale (Mean)
Itching, Week 2, n=297, 301, 305, 305Itching, Week 4, n=298, 299, 299, 305Itching, Week 8, n=297, 295, 293, 291Itching, Week 12, n=297, 295, 294, 293Burning/Stinging, Week 2, n=297, 301, 305, 305Burning/Stinging, Week 4, n=298, 2991, 299, 305Burning/Stinging, Week 8, n=297, 295, 293, 291Burning/Stinging, Week 12, n=297, 295, 294, 293
BPO Gel-0.04-0.07-0.08-0.13-0.02-0.05-0.05-0.04
Clindamycin Gel-0.18-0.18-0.24-0.28-0.06-0.09-0.09-0.13
Duac Low-dose (LD) Gel-0.11-0.11-0.16-0.210.02-0.06-0.05-0.09
Vehicle Gel-0.06-0.10-0.08-0.13-0.05-0.02-0.06-0.04

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Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling

Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline. (NCT00776919)
Timeframe: Baseline; Weeks 2, 4, 8, and 12

,,,
Interventionscores on a scale (Mean)
Erythema, Week 2, n=298, 302, 306, 306Erythema, Week 4, n=298, 300, 299, 306Erythema, Week 8, n=297, 296, 294, 293Erythema, Week 12, n=297, 296, 296, 294Dryness, Week 2, n=298, 302, 306, 306Dryness, Week 4, n=298, 300, 299, 306Dryness, Week 8, n=297, 296, 294, 293Dryness, Week 12, n=297, 296, 296, 294Peeling, Week 2, n=298, 302, 306, 306Peeling, Week 4, n=298, 300, 299, 306Peeling, Week 8, n=297, 296, 294, 293Peeling, Week 12, n=297, 296, 296, 294
BPO Gel-0.07-0.08-0.15-0.170.090.080.05-0.010.080.01-0.01-0.02
Clindamycin Gel-0.01-0.07-0.08-0.180.03-0.02-0.02-0.100.020.00-0.01-0.06
Duac Low-dose (LD) Gel-0.05-0.07-0.12-0.170.070.050.00-0.070.03-0.01-0.01-0.08
Vehicle Gel-0.02-0.06-0.08-0.130.040.000.02-0.040.020.000.00-0.04

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Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure

Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

,,,
InterventionMillimeters of mercury (mmHg) (Mean)
Systolic blood pressureDiastolic blood pressure
BPO Gel00
Clindamycin Gel01
Duac Low-dose (LD) Gel00
Vehicle Gel00

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Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

Interventionparticipants (Number)
Duac Low-dose (LD) Gel129
Clindamycin Gel82
BPO Gel100
Vehicle Gel59

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Mean Duration of Study Product Use

Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product. (NCT00776919)
Timeframe: Baseline (Day 1) through Week 12

Interventiondays (Mean)
Duac Low-dose (LD) Gel79.5
Clindamycin Gel78.0
BPO Gel78.0
Vehicle Gel77.8

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Mean Change From Baseline to Week 12 in Total Lesion Counts

During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

Interventionlesion counts (Mean)
Duac Low-dose (LD) Gel-43.0
Clindamycin Gel-35.5
BPO Gel-39.0
Vehicle Gel-27.8

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Mean Change From Baseline to Week 12 in Temperature

Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

InterventionDegrees centigrade (Mean)
Duac Low-dose (LD) Gel-0.1
Clindamycin Gel0.0
BPO Gel0.0
Vehicle Gel0.0

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Mean Change From Baseline to Week 12 in Pulse Rate

Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

InterventionBeats per minute (bpm) (Mean)
Duac Low-dose (LD) Gel1
Clindamycin Gel2
BPO Gel2
Vehicle Gel2

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Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12

During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate. (NCT00776919)
Timeframe: Week 12

Interventionparticipants (Number)
Duac Low-dose (LD) Gel209
Clindamycin Gel171
BPO Gel189
Vehicle Gel154

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Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts

During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

Interventionlesion counts (Mean)
Duac Low-dose (LD) Gel-18.2
Clindamycin Gel-15.6
BPO Gel-16.8
Vehicle Gel-13.1

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Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation

An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product. (NCT00776919)
Timeframe: Baseline (Day 1) through Week 12

,,,
Interventionparticipants (Number)
Application Site DermatitisApplication Site HypersensitivityApplication Site PruritusVaricella
BPO Gel0110
Clindamycin Gel0000
Duac Low-dose (LD) Gel1000
Vehicle Gel0011

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Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts

During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12

Interventionlesion counts (Mean)
Duac Low-dose (LD) Gel-24.8
Clindamycin Gel-19.8
BPO Gel-22.2
Vehicle Gel-14.8

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Number of Inflammatory Lesions (Papules and Pustules)

Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2. (NCT00787943)
Timeframe: 4 Weeks

,,,
InterventionLesions (Number)
Subject 1 Day 0Subject 1 Day 2Subject 1 Day 7Subject 1 Day 28Subject 2 Day 0Subject 2 Day 2Subject 2 Day 7Subject 2 Day 28Subject 3 Day 0Subject 3 Day 2Subject 3 Day 7Subject 3 Day 28Subject 4 Day 0Subject 4 Day 2Subject 4 Day 7Subject 4 Day 28Subject 5 Day 0Subject 5 Day 2Subject 5 Day 7Subject 5 Day 28Subject 6 Day 0Subject 6 Day 2Subject 6 Day 7Subject 6 Day 28Subject 7 Day 0Subject 7 Day 2Subject 7 Day 7Subject 7 Day 28Subject 8 Day 0Subject 8 Day 2Subject 8 Day 7Subject 8 Day 28Subject 9 Day 0Subject 9 Day 2Subject 9 Day 7Subject 9 Day 28Subject 10 Day 0Subject 10 Day 2Subject 10 Day 7Subject 10 Day 28
Papules: Benzoyl Peroxide 10.0% Cream Formulation #16116141577785814202110232631262214101234474635911106172122131315136
Papules: Benzoyl Peroxide 10.0% Cream Formulation #210514712489711064792328312966101130345333753719191411131879
Pustules: Benzoyl Peroxide 10.0% Cream Formulation #130012100003041011180120116336100010002011
Pustules: Benzoyl Peroxide 10.0% Cream Formulation #201020209601111112214232105714100010004120

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Percent Change in Total Acne Lesion Counts From Baseline to Week 16

Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory) (NCT00837213)
Timeframe: Baseline, Week 16

InterventionPercent Change (Mean)
Benzoyl Peroxide Wash -Clindamycin Foam-38.49
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-46.11

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Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12

Percent change in total lesions (chest and back) from baseline to Week 12 (NCT00837213)
Timeframe: Week 12

InterventionPercent change (Mean)
Benzoyl Peroxide Wash -Clindamycin Foam-44.16
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-41.74

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Change in Investigator Global Assessment (IGA)

"Change in Investigator Global Assessment (IGA) Average values chest and back.~IGA scale:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe" (NCT00837213)
Timeframe: Baseline, Weeks 4, 8,12, and 16

,
InterventionUnits on a scale (Mean)
Change from Baseline to Week 4Change from Baseline to Week 8Change from Baseline to Week 12Change from Baseline to Week 16
Benzoyl Peroxide Wash -Clindamycin Foam-0.42-0.55-1-0.9
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-0.61-0.85-1.09-1.25

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Percentage of Particpants With IGA Score at Week 16

"Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment~IGA:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe" (NCT00837213)
Timeframe: Baseline, Week 16

,
InterventionPercent of participants (Number)
% Clear skin% Clear or Almost Clear% Almost Clear% Almost clear/ mild% Mild% Mild/ Moderate% Moderate
Benzoyl Peroxide Wash -Clindamycin Foam003010102030
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules8.38.3258.3258.316.7

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Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12

Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12 (NCT00837213)
Timeframe: Baseline, Week 12

InterventionPercent Change (Mean)
Benzoyl Peroxide Wash -Clindamycin Foam-49.04
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-45.44

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Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.

Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16. (NCT00837213)
Timeframe: Baseline, Week 16

InterventionPercent Change (Mean)
Benzoyl Peroxide Wash -Clindamycin Foam-25.27
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-44.69

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Percent Change in Inflammatory Acne Lesions From Baseline to Week 16

Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back) (NCT00837213)
Timeframe: Baseline, Week 16

InterventionPercent change (Mean)
Benzoyl Peroxide Wash -Clindamycin Foam-52.70
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-48.84

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Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12

Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12 (NCT00837213)
Timeframe: Baseline, Week 12

InterventionPercent change (Mean)
Benzoyl Peroxide Wash -Clindamycin Foam-38.43
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules-38.52

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Erythema (Redness)

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8

Interventionunits on a scale (Mean)
Week 5Week 8
Clindoxyl Gel0.220.19

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Inflammatory Acne Lesion Counts

Total number of inflammatory acne lesions (pustules, papules) at each timepoint. (NCT00887484)
Timeframe: Baseline, Weeks 5 and 8

InterventionAcne Lesions (Mean)
BaselineWeek 5Week 8
Clindoxyl Gel14.234.604.26

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Investigators Static Global Assessment

ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. (NCT00887484)
Timeframe: Baseline, Weeks 5, 8

Interventionunits on a scale (Mean)
BaselineWeek 5Week 8
Clindoxyl Gel2.771.891.62

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Quality of Life Questionnaire - Global Score

Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8

InterventionUnits on a scale (Mean)
BaselineWeek 2Week 8
Clindoxyl Gel8.596.305.19

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Quality of Life Questionnaire - Functional Domain

Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8

InterventionUnits on a scale (Mean)
BaselineWeek 2Week 8
Clindoxyl Gel8.596.305.19

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Quality of Life Questionnaire - Emotional Domain

Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8

InterventionUnits on a scale (Mean)
BaselineWeek 2Week 8
Clindoxyl Gel25.3219.3816.42

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Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally. (NCT00887484)
Timeframe: Weeks 1 and 2

InterventionParticipants (Number)
Week 1, Epiduo Gel, n=47Week 1, Clindoxyl Gel, n=47Week 1, Both Treatments Equally, n=47Week 2, Epiduo Gel, n=46Week 2, Clindoxyl Gel, n=46Week 2, Both Treatments Equally, n=46
All Subjects1530216291

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Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8

Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? (NCT00887484)
Timeframe: Week 8

InterventionParticipants (Number)
YesNo
Clindoxyl Gel415

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Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionParticipants (Number)
Week 1 - YesWeek 1 - NoWeek 2 - YesWeek 2 - No
Clindoxyl Gel443397
Epiduo Gel26213214

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Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.790.59
Epiduo Gel1.431.04

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Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel1.090.72
Epiduo Gel1.721.15

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Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.640.72
Epiduo Gel1.020.93

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Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel1.301.00
Epiduo Gel1.811.41

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Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.910.72
Epiduo Gel1.681.30

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Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel2.091.76
Epiduo Gel2.231.98

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Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionParticipants (Number)
Week 1 - YesWeek 1 - NoWeek 2 - YesWeek 2 - No
Clindoxyl Gel16311432
Epiduo Gel12351135

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Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? (NCT00887484)
Timeframe: Week 8

InterventionParticipants (Number)
YesNo
Clindoxyl Gel2818

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Product Acceptability and Preference Questionnaire - Compliance at Week 8

Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale. (NCT00887484)
Timeframe: Week 8

InterventionParticipants (Number)
YesNo
Clindoxyl Gel433

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Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel1.871.85
Epiduo Gel2.042.00

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Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel1.911.85
Epiduo Gel1.911.85

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Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel2.812.39
Epiduo Gel3.152.67

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Non-inflammatory Acne Lesion Counts

Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. (NCT00887484)
Timeframe: Baseline, Weeks 5 and 8

InterventionAcne Lesions (Mean)
BaselineWeek 5Week 8
Clindoxyl Gel24.8311.369.51

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Irritant/Allergic Contact Dermatitis

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8

Interventionunits on a scale (Mean)
Week 5Week 8
Clindoxyl Gel0.000.00

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Irritant/Allergic Contact Dermatitis

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 1 and 2

,
Interventionunits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.040.04
Epiduo Gel0.040.04

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Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel1.301.35
Epiduo Gel1.321.39

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Total Acne Lesion Counts

Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), (NCT00887484)
Timeframe: Baseline, Weeks 5 and 8

InterventionAcne Lesions (Mean)
BaselineWeek 5Week 8
Clindoxyl Gel39.0615.9613.77

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Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain

Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8

InterventionUnits on a scale (Mean)
BaselineWeek 2Week 8
Clindoxyl Gel20.9121.5813.75

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Skin Peeling

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense." (NCT00887484)
Timeframe: Weeks 1 and 2

,
Interventionunits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.340.40
Epiduo0.680.60

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Skin Peeling

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8

Interventionunits on a scale (Mean)
Week 5Week 8
Clindoxyl Gel0.130.06

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Skin Dryness

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8

Interventionunits on a scale (Mean)
Week 5Week 8
Clindoxyl Gel0.200.04

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Skin Dryness

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 1 and 2

,
Interventionunits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.470.40
Epiduo Gel0.960.64

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Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel0.45

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Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel1.83

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Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel1.63

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Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel1.53

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Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel1.26

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Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel1.69

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Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel1.61

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Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel0.36

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Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel0.64

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Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel0.26

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Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Clindoxyl Gel0.77

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Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2

Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. (NCT00887484)
Timeframe: Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel2.231.75
Epiduo Gel2.311.75

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Erythema (Redness)

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 1 and 2

,
Interventionunits on a scale (Mean)
Week 1Week 2
Clindoxyl Gel0.660.55
Epiduo Gel0.910.74

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Worst Post Baseline Tolerability Assessment - Stinging/Burning

Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs. (NCT00907101)
Timeframe: Week 4

Interventionparticipants (Number)
NoneMild
Epiduo® Gel291

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Change From Baseline in Quantitative Bacteriology Measurements at Week 4

Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm². (NCT00907101)
Timeframe: Week 4

Interventionlog10 CFU/cm2 (Mean)
Epiduo® Gel-1.6

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Worst Post Baseline Tolerability Assessment - Dryness

Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs. (NCT00907101)
Timeframe: Week 4

Interventionparticipants (Number)
NoneMild
Epiduo® Gel264

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Worst Post Baseline Tolerability Assessment - Erythema

Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs. (NCT00907101)
Timeframe: Week 4

Interventionparticipants (Number)
NoneMild
Epiduo® Gel300

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Worst Post Baseline Tolerability Assessment - Scaling

Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs. (NCT00907101)
Timeframe: Week 4

Interventionparticipants (Number)
NoneMild
Epiduo® Gel291

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Measurement of Success

"Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:~0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe." (NCT00907257)
Timeframe: Baseline to Week 12

,
InterventionParticipants (Number)
Clear / Almost ClearImproved Two Categories
Different Times of Day2554
Same Time of Day2651

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Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals

Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions). (NCT00907257)
Timeframe: Baseline to Week 12

,
InterventionLesions (Least Squares Mean)
Inflammatory LesionsNon-Inflammatory LesionsTotal Lesions
Different Times of Day14.223.738.1
Same Time of Day14.623.237.4

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Change From Baseline in Total Facial Acne Lesion Count

Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement. (NCT00907257)
Timeframe: Baseline to Week 12

InterventionLesions (Least Squares Mean)
Same Time of Day39.74
Different Times of Day40.02

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Change From Baseline in Total Non-inflammatory Lesion Count

Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. (NCT00907335)
Timeframe: Baseline to Week 12

InterventionLesions (Least Squares Mean)
Retin-A Micro-19.9
Vehicle Control-9.7

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Measurement of Success 2

Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. (NCT00907335)
Timeframe: Week 12

,
InterventionParticipants (Number)
Clear/Almost ClearAt Least 2 Grades Improvement
Retin-A Micro108
Vehicle Control108

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Measurement of Success 3

"Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of Excellent or Good scores." (NCT00907335)
Timeframe: Week 12

,
InterventionParticipants (Number)
SuccessNo Success
Retin-A Micro3116
Vehicle Control2727

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Measurement of Success 1

Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. (NCT00907335)
Timeframe: Week 12

,
InterventionParticipants (Number)
Clear/Almost ClearAt Least 2 Grades Improvement
Retin-A Micro1115
Vehicle Control1112

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Global Assessment

Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. (NCT00907335)
Timeframe: Baseline to Week 12

,
InterventionParticipants (Number)
ExcellentGoodFairNo ChangeWorse
Retin-A Micro12191150
Vehicle Control7209180

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Change From Baseline in Lesion Counts

Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. (NCT00907335)
Timeframe: Baseline to Week 12

,
InterventionLesions (Least Squares Mean)
ComedonesInflammatoryTotal LesionsOpen ComedonesClosed ComedonesPapulesPustules
Retin-A Micro-19.85-0.63-21.87-4.10-15.16-0.62-0.17
Vehicle Control-9.670.54-10.88-2.86-6.09-0.481.04

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Self Assessment of Burning/Stinging and Itching

Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe (NCT00919191)
Timeframe: Daily, for 3 weeks

,
InterventionScores on a Scale (Mean)
Cumulative Burning/StingingCumulative Itching
Adapalene Benzoyl Peroxide Facial Gel3.71.9
Tretinoin Facial Gel1.40.7

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Comparative Assessment of Facial Irritation and Cutaneous Effects.

Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe (NCT00919191)
Timeframe: Daily, for 3 weeks

,
InterventionScores on a Scale (Mean)
Cumulative ErythemaCumulative Dryness
Adapalene Benzoyl Peroxide Facial Gel2.76.2
Tretinoin Facial Gel1.13.2

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Skin Erythema (Redness)

"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion" (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
InterventionUnits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac1.562.622.903.083.173.072.872.782.892.852.73
Epiduo1.892.652.522.813.133.082.983.032.942.832.56

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Skin Dryness

"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.120.410.320.460.610.690.600.730.560.800.79
Epiduo0.070.250.340.551.731.851.872.291.491.261.33

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Self Assessment of Texture (Roughness)

"The amount of roughness on the left and right cheek of each panelist.~The scale used to evaluate roughness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.280.200.160.320.280.330.250.290.290.330.29
Epiduo0.150.070.070.070.330.190.30.150.150.120.15

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Self Assessment of Stinging

"The amount of stinging on the left and right cheek of each panelist.~The scale used to evaluate stinging is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.000.080.080.120.10.170.170.130.130.130.08
Epiduo0.000.000.000.040.40.300.350.150.120.190.12

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Self Assessment of Pain

"The amount of pain on the left and right cheek of each panelist.~The scale used to evaluate pain is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.000.040.040.040.040.040.040.040.040.040.04
Epiduo0.000.040.000.000.10.040.040.000.000.000.00

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Self Assessment of Oiliness

"The amount of oiliness on the left and right cheek of each panelist.~The scale used to evaluate oiliness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.120.080.000.080.040.000.000.000.000.000.00
Epiduo0.190.110.040.110.040.070.040.080.00.120.08

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Self Assessment of Dryness

"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate dryness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.240.20.160.240.480.540.540.540.500.500.46
Epiduo0.300.190.150.20.670.700.810.850.690.730.69

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Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?

"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?~The subject replied using the following scale:~0 - Not Compliant at all (<50%)~- Mostly Compliant (50%-79%)~- Very Compliant (80%-100%)" (NCT00926367)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Duac2.00
Epiduo2.00

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Self Assessment of Crusting

"The amount of crusting on the left and right cheek of each panelist.~The scale used to evaluate crusting is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.000.000.000.000.000.000.000.000.000.000.00
Epiduo0.000.000.000.000.070.040.040.040.040.000.00

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Self Assessment of Burning

"The amount of burning on the left and right cheek of each panelist.~The scale used to evaluate burning is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.000.040.040.120.120.170.170.130.130.080.08
Epiduo0.000.040.040.150.560.700.500.270.310.350.19

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Self Assessment of Blistering

"The amount of blistering on the left and right cheek of each panelist.~The scale used to evaluate blistering is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14

,
Interventionunits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Duac0.000.000.000.000.000.000.000.000.000.000.00
Epiduo0.000.000.000.000.070.040.000.000.000.000.00

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Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?

"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?~The subject replied using the following scale:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied" (NCT00926367)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Duac2.29
Epiduo2.46

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Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?

"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult" (NCT00926367)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Duac1.04
Epiduo1.46

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Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?

"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult" (NCT00926367)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Duac1.17
Epiduo1.00

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Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?

"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?~The subject replied using the following scale:~- Very Comfortable~- Comfortable~- Somewhat Comfortable~- Somewhat Uncomfortable~- Uncomfortable" (NCT00926367)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Duac2.38
Epiduo2.23

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Skin Hydration

"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration." (NCT00926367)
Timeframe: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14

,
InterventionMicrosiemens (Mean)
Baseline4 hrs Post 1st TreatmentDay 3Day 7Day 14
Duac378.06323.47420.97385.91401.98
Epiduo392.09415.90465.25414.77418.51

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Skin Moisture and Hydration

"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss." (NCT00926367)
Timeframe: Baseline, Days 3, 7, and 14

,
InterventionTEWL rates (gm/m2/hr) (Mean)
BaselineDay 3Day 7Day 14
Duac11.5011.3814.5113.36
Epiduo13.0715.8521.6519.28

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Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?

"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?~The subject replied using the following scale:~1 - Yes 0 - No" (NCT00926367)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Duac0.58
Epiduo0.54

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Facial Irritation and Cutaneous Effects

Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared. (NCT00952523)
Timeframe: three weeks

,
InterventionScores on a Scale (Mean)
ErythemaDrynessBurning/StingingItching
Adapalene-Benzoyl Peroxide Facial Gel5.47.85.82.9
Tretinoin Facial Gel1.53.11.91.0

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Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel2.07

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Product Acceptability and Preference Questionnaire - Ease of Application of Product

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel1.26

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Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up

Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel1.89

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Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel2.52

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Product Acceptability and Preference Questionnaire - Severity of Burning

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel0.63

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Product Acceptability and Preference Questionnaire - Severity of Dryness

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel1.22

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Product Acceptability and Preference Questionnaire - Severity of Itching

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel0.63

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Product Acceptability and Preference Questionnaire - Severity of Redness

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel1.00

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Product Acceptability and Preference Questionnaire - Severity of Scaling

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel0.78

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Erythema (Redness) Score

Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8

InterventionUnits on a scale (Mean)
Week 5Week 8
Duac Gel0.260.19

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Erythema (Redness) Score

Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel0.270.18
Epiduo Gel0.580.36

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Inflammatory Acne Lesion Counts

Total number of inflammatory acne lesions (pustules, papules) at each timepoint. (NCT00964223)
Timeframe: Week 5, Week 8

Interventioninflammatory acne lesions (Mean)
Week 5Week 8
Duac Gel8.447.00

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Investigator Static Global Assessment Score

ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. (NCT00964223)
Timeframe: Week 5, Week 8

InterventionUnits on a scale (Mean)
Week 5Week 8
Duac Gel2.632.15

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Irritant/Allergic Contact Dermatitis Score

"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face.~Erythema,peeling, and dryness were graded using the following scale:~0 None~Slight~Moderate~Intense" (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel0.000.00
Epiduo Gel0.150.00

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Non-Inflammatory Acne Lesion Counts

Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. (NCT00964223)
Timeframe: Week 5, Week 8

Interventionnon-inflammatory acne lesions (Mean)
Week 5Week 8
Duac Gel14.3710.81

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Product Acceptability and Preference Questionnaire - Comfort of Skin

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel2.382.00
Epiduo Gel2.582.25

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Product Acceptability and Preference Questionnaire - Compliance

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%). (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel1.961.93
Epiduo Gel1.931.93

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Product Acceptability and Preference Questionnaire - Compliance

Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No (NCT00964223)
Timeframe: Week 8

InterventionParticipants (Number)
YesNo
Duac Gel243

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Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel2.272.14
Epiduo Gel2.272.07

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Product Acceptability and Preference Questionnaire - Ease of Application of Product

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel1.461.43
Epiduo Gel1.501.50

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Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel2.311.59
Epiduo Gel2.381.59

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Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin

Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionParticipants (Number)
Week 1 - YesWeek 1 - NoWeek 2 - YesWeek 2 - No
Duac Gel188198
Epiduo Gel1610189

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Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin

Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). (NCT00964223)
Timeframe: Week 8

InterventionParticipants (Number)
YesNo
Duac Gel243

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Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel2.042.21
Epiduo Gel2.192.32

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Product Acceptability and Preference Questionnaire - Severity of Burning

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel1.120.73
Epiduo Gel1.961.11

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Product Acceptability and Preference Questionnaire - Severity of Dryness

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel1.421.31
Epiduo Gel1.881.58

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Product Acceptability and Preference Questionnaire - Severity of Itching

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel1.190.81
Epiduo Gel1.421.19

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Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment

Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionParticipants (Number)
Week 1 - YesWeek 1 - NoWeek 2 - YesWeek 2 - No
Duac Gel1951610
Epiduo Gel1510189

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Product Acceptability and Preference Questionnaire - Severity of Scaling

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel0.770.69
Epiduo Gel1.151.00

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Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment

Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). (NCT00964223)
Timeframe: Week 8

InterventionParticipants (Number)
YesNo
Duac Gel207

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Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?

Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionParticipants (Number)
Week 1Week 2
Duac Gel1712
Epiduo Gel815

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Skin Dryness Score

Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel0.150.14
Epiduo Gel0.460.29

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Skin Dryness Score

Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8

InterventionUnits on a scale (Mean)
Week 5Week 8
Duac Gel0.150.00

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Skin Peeling Score

Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8

InterventionUnits on a scale (Mean)
Week 5Week 8
Duac Gel0.000.00

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Skin Peeling Score

Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel0.150.18
Epiduo Gel0.540.21

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Skindex-29 Quality of Life Questionnaire - Emotional Domain

"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8

InterventionUnits on a scale (Mean)
BaselineWeek 8
Duac Gel44.2935.37

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Skindex-29 Quality of Life Questionnaire - Functional Domain

"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8

InterventionUnits on a scale (Mean)
BaselineWeek 8
Duac Gel14.069.10

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Skindex-29 Quality of Life Questionnaire - Global Score

"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8

InterventionUnits on a scale (Mean)
BaselineWeek 8
Duac Gel14.069.10

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Skindex-29 Quality of Life Questionnaire - Symptomatic Domain

"Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8

InterventionUnits on a scale (Mean)
BaselineWeek 8
Duac Gel28.1021.72

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Total Acne Lesion Counts

Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), (NCT00964223)
Timeframe: Week 5, Week 8

Interventiontotal acne lesions (Mean)
Week 5Week 8
Duac Gel22.8117.81

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Irritant/Allergic Contact Dermatitis Score

Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8

InterventionUnits on a scale (Mean)
Week 5Week 8
Duac Gel0.040.00

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Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel1.93

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Product Acceptability and Preference Questionnaire - Severity of Redness

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2

,
InterventionUnits on a scale (Mean)
Week 1Week 2
Duac Gel1.120.78
Epiduo Gel1.541.00

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Product Acceptability and Preference Questionnaire - Comfort of Skin

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. (NCT00964223)
Timeframe: Week 8

InterventionUnits on a scale (Mean)
Duac Gel1.78

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Skin Erythema (Redness)

"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion" (NCT00964366)
Timeframe: 2 Weeks

,
InterventionUnits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO Gel1.061.261.551.321.301.641.801.671.811.522.10
Dapsone Gel1.181.341.331.501.651.531.601.451.851.651.90

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Skin Hydration

Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site. (NCT00964366)
Timeframe: 2 weeks

,
InterventionMicrosiemens (Mean)
Baseline4 hours post 1st treatmentDay 3Day 7Day 14
Clindamycin and BPO Gel499.51430.38614.73460.65477.80
Dapsone Gel448.31404.68511.63456.73471.13

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Transepidermal Water Loss (TEWL)

To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale. (NCT00964366)
Timeframe: 2 Weeks

,
InterventionTEWL rates (gm/m2/hr) (Mean)
BaselineDay 3Day 7Day 14
Clindamycin and BPO Gel10.2912.3414.3913.88
Dapsone Gel10.411.2111.5311.26

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Skin Dryness

"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00964366)
Timeframe: Baseline, Day 1through Day 14

,
InterventionUnits on a scale (Mean)
BaselineDay 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO Gel0.110.040.100.160.270.210.540.50.570.570.55
Dapsone Gel0.120.280.230.480.370.230.170.100.150.170.12

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Sebum Measurements

To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced. (NCT00964366)
Timeframe: 2 weeks

,
Interventionunits on a scale (Mean)
BaselineDay 3Day 7Day 14
Clindamycin and BPO Gel1.721.522.652.35
Dapsone Gel2.181.723.332.38

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Subject Assessment - Crusting

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here." (NCT01015638)
Timeframe: 2 Weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.000.000.000.000.000.000.000.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.000.000.000.000.000.000.000.000.000.000.00

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Subject Assessment - Dryness

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here." (NCT01015638)
Timeframe: 2 weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.000.000.060.120.120.20.240.350.24
Clindamycin Phosphate and BPO 2.5% Gel0.260.260.210.110.110.210.160.160.160.160.21

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Subject Assessment - Blistering

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here." (NCT01015638)
Timeframe: 2 Weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.000.000.000.000.000.000.000.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.000.000.000.000.000.000.000.000.000.000.00

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Changes in the Skin Surface Hydration

"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration." (NCT01015638)
Timeframe: 14 days

,
Interventionmicrosiemens (Mean)
Day 04 Hours Post 1st TreatmentDay 3Day 7Day 14
Clindamycin and BPO 5% Gel546.40554.00572.39484.94361.59
Clindamycin Phosphate and BPO 2.5% Gel478.02430.78529.96413.51354.46

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Erythema (Redness)

"Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.~Erythema (redness) was evaluated using the following scale:~Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion" (NCT01015638)
Timeframe: 14 days

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.941.421.451.271.551.721.391.381.781.341.51
Clindamycin Phosphate and BPO 2.5% Gel1.051.241.491.361.871.881.701.821.721.821.82

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Skin Dryness

"Visual Dryness was evaluated using the following scale:~Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring" (NCT01015638)
Timeframe: 14 days

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.060.050.050.270.290.320.400.350.470.760.62
Clindamycin Phosphate and BPO 2.5% Gel0.050.150.370.220.240.150.150.150.360.280.31

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Skin Moisture and Hydration

"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration." (NCT01015638)
Timeframe: 14 days

,
Interventiongrams/m^2/hour (Mean)
Day 0Day 3Day 7Day 14
Clindamycin and BPO 5% Gel10.8211.9813.0113.94
Clindamycin Phosphate and BPO 2.5% Gel9.7110.8411.3613.59

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Subject Assessment - Oiliness

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here." (NCT01015638)
Timeframe: 2 Weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.180.180.060.120.060.060.060.060.000.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.160.050.000.110.000.000.000.000.000.000.00

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Subject Assessment - Pain

"At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.~Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here." (NCT01015638)
Timeframe: 2 Weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.000.000.000.000.000.000.000.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.000.000.000.000.000.000.000.000.000.000.00

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Subject Assessment - Roughness

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here." (NCT01015638)
Timeframe: 2 weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.000.000.060.060.060.180.120.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.000.050.000.000.000.000.050.050.050.050.05

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Subject Tolerability - Burning

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here." (NCT01015638)
Timeframe: 2 weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.000.000.000.000.000.000.000.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.000.000.000.000.000.000.000.000.000.000.00

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Subject Tolerability - Stinging

"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here." (NCT01015638)
Timeframe: 2 weeks

,
Interventionunits on a scale (Mean)
Day 0Day 1Day 2Day 3Day 6Day 7Day 8Day 9Day 10Day 13Day 14
Clindamycin and BPO 5% Gel0.000.000.060.000.000.000.000.000.000.000.00
Clindamycin Phosphate and BPO 2.5% Gel0.000.000.000.050.050.000.000.000.050.000.11

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Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel0.760.840.650.300.45
Tazorac Cream/Duac Gel0.680.100.20-0.050.35

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Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel-1.29-1.05-0.55-1.05-0.75
Tazorac Cream/Duac Gel-1.00-0.95-0.85-0.80-0.35

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Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel1.060.790.550.10-0.05
Tazorac Cream/Duac Gel1.111.050.600.500.20

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Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12

Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60. (NCT01016977)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Tazorac Cream/Duac Gel-6.1
Tazorac Cream/Acanya Gel-3.7

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Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12

Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150. (NCT01016977)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Tazorac Cream/Duac Gel-6.1
Tazorac Cream/Acanya Gel-3.7

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Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel0.760.470.550.200.10
Tazorac Cream/Duac Gel0.790.600.500.200.25

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Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12

Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35. (NCT01016977)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Tazorac Cream/Duac Gel-8.7
Tazorac Cream/Acanya Gel-1.4

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Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12

The investigator conducted the overall assessment of the participant's facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT01016977)
Timeframe: Baseline and Week 12

Interventionparticipants (Number)
Tazorac Cream/Duac Gel7
Tazorac Cream/Acanya Gel10

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Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel1.650.840.550.450.40
Tazorac Cream/Duac Gel1.580.701.250.600.50

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Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel1.180.840.550.15-0.05
Tazorac Cream/Duac Gel1.111.150.650.500.20

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Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12

Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionlesions (Mean)
W1, Inflammatory lesions, n=19, 17W2, Inflammatory lesions, n=20, 19W4, Inflammatory lesions, n=20, 20W8, Inflammatory lesions, n=20, 20W12, Inflammatory lesions, n=20, 20W1, Non-inflammatory lesions, n=19, 17W2, Non-inflammatory lesions, n=20, 19W4, Non-inflammatory lesions, n=20, 20W8, Non-inflammatory lesions, n=20, 20W12, Non-inflammatory lesions, n=20, 20
Tazorac Cream/Acanya Gel-5.9-8.1-9.6-16.3-13.4-7.6-15.1-26.6-33.1-37.8
Tazorac Cream/Duac Gel-6.6-8.8-13.0-14.9-18.0-3.2-17.9-23.6-28.9-32.6

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Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12

Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50. (NCT01016977)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Tazorac Cream/Duac Gel-11.2
Tazorac Cream/Acanya Gel-7.1

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Overall Satisfaction With Study Product at Week 12

"Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): What is your overall satisfaction with the study product. Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied." (NCT01016977)
Timeframe: Week 12

,
Interventionunits on a scale (Mean)
MorningEvening
Tazorac Cream/Acanya Gel1.751.70
Tazorac Cream/Duac Gel1.761.59

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Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12

The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionlesions (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel-13.5-23.1-36.2-49.4-51.1
Tazorac Cream/Duac Gel-9.8-26.6-36.6-43.7-50.6

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Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12

Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 1, n=19, 17Week 2, n=20, 19Week 4, n=20, 20Week 8, n=20, 20Week 12, n=20, 20
Tazorac Cream/Acanya Gel-0.290.05-0.100.100.60
Tazorac Cream/Duac Gel-0.370.250.050.300.45

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Reduction of Inflammatory Lesions

The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules). (NCT01044264)
Timeframe: Baseline and week 11

Interventionpercentage reduction of lesions (Number)
1% Clindamycin/5% Benzoyl Peroxide Topical Gel64.39
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel63.10
Placebo49.89

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Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)

Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10. (NCT01138514)
Timeframe: 10 weeks

Interventionparticipants (Number)
Clindamycin 1%/Benzoyl Peroxide 5%247
Reference Product234
Vehicle79

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Percent Change From Baseline in Inflammatory Lesions

(NCT01138514)
Timeframe: 10 weeks

Interventionpercentage of lesion reduction (Mean)
Clindamycin 1%/Benzoyl Peroxide 5%79.87
Reference Product80.86
Vehicle45.60

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Percent Change From Baseline in Non-inflammatory Lesions

(NCT01138514)
Timeframe: 10 weeks

Interventionpercentage of lesion reduction (Mean)
Clindamycin 1%/Benzoyl Peroxide 5%70.21
Reference Product70.02
Vehicle36.16

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Change From Baseline in Total Lesion Counts

(NCT01138735)
Timeframe: Baseline to Week 12 (LOCF)

Interventionlesion count change (Mean)
Adapalene/Benzoyl Peroxide-27.6
Topical Gel Vehicle-3.6

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Change in Inflammatory Lesion Counts From Baseline

(NCT01138735)
Timeframe: Baseline to Week 12 (LOCF)

Interventionlesion count change (Mean)
Adapalene/Benzoyl Peroxide-7.4
Topical Gel Vehicle-0.7

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Percent Change in Total Lesion Counts From Baseline

(NCT01138735)
Timeframe: Baseline to Week 12 (LOCF)

Interventionpercentage of change in lesion count (Mean)
Adapalene/Benzoyl Peroxide-55.5
Topical Gel Vehicle-9.3

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Success Rate

Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA) (NCT01138735)
Timeframe: Baseline to Week 12 (Last Observation Carried Forward [LOCF])

Interventionpercentage of participant (Number)
Adapalene/Benzoyl Peroxide47.2
Topical Gel Vehicle15.4

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The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.

Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale. (NCT01176955)
Timeframe: Baseline to 12 weeks

Interventionunits on a scale (Mean)
Internet Survey-0.71
Control-0.25

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The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.

All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment. (NCT01176955)
Timeframe: 12 weeks

InterventionSpearman's Rank Correlation Coefficient (Number)
All Participants0.53

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The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.

Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day. (NCT01176955)
Timeframe: 12 weeks

Interventionpercentage of days containers were open (Median)
Internet Survey74
Control32

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The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.

Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated. (NCT01176955)
Timeframe: Baseline to 12 weeks

Interventionpercent change in lesion count (Mean)
Internet Survey-36
Control-8

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Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12

Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst. (NCT01209949)
Timeframe: 12 weeks

Interventionparticipants (Number)
Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel18

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Number of Participants With Tolerability Assessments Resulting in an Adverse Event

Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst. (NCT01209949)
Timeframe: 12 weeks

Interventionparticipants (Number)
Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel2

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Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.

Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12. (NCT01209949)
Timeframe: Week 12

Interventionpercent change from baseline (Mean)
Inflammatory LesionsNoninflammatory LesionsTotal Lesions
Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel-44.1-57.1-49.7

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Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12

The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated. (NCT01231334)
Timeframe: Baseline, Week 12

,
InterventionPercentage of participants (Number)
DrynessPeelingOilinessErythemaPruritusBurning
Aczone® Gel 5% Plus Differin® 0.3% Gel21.311.56.78.212.413.2
Duac® Topical Gel Plus Differin® 0.3% Gel11.99.36.06.88.512.7

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Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12

GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement. (NCT01231334)
Timeframe: Baseline, Week 12

,
InterventionScore on a scale (Mean)
BaselineChange from baseline at Week 12
Aczone® Gel 5% Plus Differin® 0.3% Gel2.80-0.87
Duac® Topical Gel Plus Differin® 0.3% Gel2.84-1.27

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Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12

GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated. (NCT01231334)
Timeframe: Baseline, Week 12

InterventionPercentage of participants (Number)
Aczone® Gel 5% Plus Differin® 0.3% Gel69.7
Duac® Topical Gel Plus Differin® 0.3% Gel81.4

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Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity

The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated. (NCT01231334)
Timeframe: Baseline, Week 12

InterventionPercentage of participants (Number)
Aczone® Gel 5% Plus Differin® 0.3% Gel83.5
Duac® Topical Gel Plus Differin® 0.3% Gel92.4

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Percent Change From Baseline in Total Lesion Count at Week 12

Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement). (NCT01231334)
Timeframe: Baseline, Week 12

InterventionPercent change (Median)
Aczone® Gel 5% Plus Differin® 0.3% Gel-62.7
Duac® Topical Gel Plus Differin® 0.3% Gel-65.0

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Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). (NCT01231334)
Timeframe: Baseline, Week 12

InterventionPercent change (Median)
Aczone® Gel 5% Plus Differin® 0.3% Gel-70.7
Duac® Topical Gel Plus Differin® 0.3% Gel-75.9

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Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12

"Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)." (NCT01231334)
Timeframe: Baseline, Week 12

InterventionPercent change (Median)
Aczone® Gel 5% Plus Differin® 0.3% Gel-55.3
Duac® Topical Gel Plus Differin® 0.3% Gel-60.7

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Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12

The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center. (NCT01400932)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

,
InterventionLesion counts (Least Squares Mean)
IL, Week 1, n=175, 179IL, Week 2, n=177, 182IL, Week 4, n=177, 182IL, Week 8, n=177, 182IL, Week 12, n=177, 182NIL, Week 1, n=175, 179NIL, Week 2, n=177, 182NIL, Week 4, n=177, 182NIL, Week 8, n=177, 182NIL, Week 12, n=177, 182
GI148512-8.2-12.3-14.9-16.8-18.3-7.7-12.2-17.1-22.8-24.6
Vehicle Gel-4.6-5.8-8.4-7.8-9.6-3.7-7.5-8.4-12.3-12.3

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Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions. (NCT01400932)
Timeframe: Baseline and Week 12

InterventionParticipants (Number)
GI14851231
Vehicle Gel2

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Absolute Change in Total Lesion Counts From Baseline to Week 12

The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. (NCT01400932)
Timeframe: Baseline and Week 12

InterventionLesion counts (Least Squares Mean)
GI148512-42.9
Vehicle Gel-22.0

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Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal

Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value. (NCT01400932)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal

,
InterventionScores on a scale (Mean)
Itching, Week 1, n=177, 181Itching, Week 2, n=177, 176Itching, Week 4, n=173, 174Itching, Week 8, n=164, 168Itching, Week 12, n=164, 167Itching, Withdrawal, n=12, 15Burning/Stinging, Week 1, n=177, 181Burning/Stinging, Week 2, n=177, 176Burning/Stinging, Week 4, n=173, 174Burning/Stinging, Week 8, n=164, 168Burning/Stinging, Week 12, n=164, 167Burning/Stinging,Withdrawal, n=12, 15
GI148512-0.010.010.01-0.04-0.071.330.150.150.050.040.051.00
Vehicle Gel-0.12-0.13-0.14-0.11-0.120.20-0.04-0.03-0.02-0.02-0.040.73

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Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12

The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100. (NCT01400932)
Timeframe: Baseline; Weeks 1, 2, 4 and 8 and 12

,
InterventionPercent change in lesion counts (Least Squares Mean)
Total, Week 1, n=175, 179Total, Week 2, n=177, 182Total, Week 4, n=177, 182Total, Week 8, n=177, 182Total, Week 12, n=177,182IL, Week 1, n=175, 179IL, Week 2, n=177, 182IL, Week 4, n=177, 182IL, Week 8, n=177, 182IL, Week 12, n=177,182NIL, Week 1, n=175, 179NIL, Week 2, n=177, 182NIL, Week 4, n=177, 182NIL, Week 8, n=177, 182NIL, Week 12, n=177,182
GI148512-22.26-36.17-45.43-55.40-59.79-30.85-46.40-54.38-60.33-64.68-16.99-29.78-39.88-51.64-55.17
Vehicle Gel-12.07-19.63-24.50-27.43-30.15-16.78-20.74-30.54-28.02-36.16-7.92-17.93-19.72-25.86-26.36

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Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12

Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions. (NCT01400932)
Timeframe: Weeks 1, 2, 4, 8, and 12

,
InterventionParticipants (Number)
Week 1, n=175, 179Week 2, n=177, 179Week 4, n=176, 178Week 8, n= 168, 173Week 12, n=164, 166
GI14851246121635
Vehicle Gel10133

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Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12

The proportion of participants who have a reduction in total lesions (inflammatory and non-inflammatory) of at least 50% from Baseline at Weeks 1, 2, 4, 8, and 12 was measured. (NCT01400932)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

,
InterventionParticipants (Number)
Week 1, n=175, 179Week 2, n=177, 182Week 4, n=177, 182Week 8, n= 177, 182Week 12, n=177, 182
GI148512256086115116
Vehicle Gel732385473

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Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal

Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value. (NCT01400932)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal

,
InterventionScores on a scale (Mean)
Erythema, Week 1, n=177, 181Erythema, Week 2, n=177, 176Erythema, Week 4, n=173, 174Erythema, Week 8, n= 164, 168Erythema, Week 12, n=164, 167Erythema, Withdrawal, n=12, 15Dryness, Week 1, n=177, 181Dryness, Week 2, n=177, 176Dryness, Week 4, n=173, 174Dryness, Week 8, n=164, 168Dryness, Week 12, n=164, 167Dryness, Withdrawal, n=12, 15Peeling, Week 1, n=177, 181Peeling, Week 2, n=177, 176Peeling, Week 4, n=173, 174Peeling, Week 8, n=164, 168Peeling, Week 12, n=164, 167Peeling, Withdrawal, n=12, 15
GI148512-0.03-0.07-0.13-0.19-0.191.170.160.140.060.00-0.040.580.010.02-0.01-0.01-0.020.42
Vehicle Gel-0.13-0.19-0.20-0.23-0.260.47-0.08-0.06-0.06-0.08-0.110.33-0.03-0.030.00-0.01-0.050.13

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Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8

The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center. (NCT01400932)
Timeframe: Baseline; Weeks 1, 2, 4, and 8

,
InterventionLesion counts (Least Squares Mean)
Week 1, n=175, 179Week 2, n=177, 182Week 4, n=177, 182Week 8, n=177, 182
GI148512-15.9-24.4-32.0-39.6
Vehicle Gel-8.3-13.3-16.8-20.1

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Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit

The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). (NCT01446237)
Timeframe: Week 1, 2, 4, 8 and 12

InterventionParticipants (Number)
Week 1Week 2Week 4Week 8Week 12
MaxClarity1241020

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Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit

The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. (NCT01446237)
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12

InterventionLesions (Mean)
IL Week 1IL Week 2IL Week 4IL Week 8IL Week 12NIL Week 1NIL Week 2NIL Week 4NIL Week 8NIL Week 12TL Week 1TL Week 2TL Week 4TL Week 8TL Week 12
MaxClarity-9.6-14.3-16.9-18.9-21.4-7.4-13.4-17.6-20.1-25.6-17.0-27.7-34.5-38.9-47.0

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Mean Change in ISGA From Baseline to Each Study Visit

The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. (NCT01446237)
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12

InterventionScores on a scale (Mean)
Week 1Week 2Week 4Week 8Week 12
MaxClarity-0.29-0.45-0.63-0.79-1.05

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Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit

The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented. (NCT01446237)
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12

InterventionPercent change in lesions (Mean)
IL Week 1IL Week 2IL Week 4IL Week 8IL Week 12NIL Week 1NIL Week 2NIL Week 4NIL Week 8NIL Week 12TL Week 1TL Week 2TL Week 4TL Week 8TL Week 12
MaxClarity-30.4-44.8-52.9-59.8-67.1-14.8-28.5-37.1-43.8-57.3-22.2-36.0-44.4-51.0-61.6

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Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit

The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. (NCT01446237)
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12

InterventionParticipants (Number)
Week 1Week 2Week 4Week 8Week 12
MaxClarity36121931

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Change in Acne Global Assessment

Change in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit. (NCT01504204)
Timeframe: Baseline and 6 weeks

InterventionParticipants (Count of Participants)
Baseline71966884Baseline71966885Week 671966884Week 671966885
AGA (2-mild)AGA (3 moderate)AGA (1 almost clear)
Medication With Sample and Demonstration5
Medication Without Samples6
Medication With Sample and Demonstration4
Medication With Sample and Demonstration0
Medication Without Samples0
Medication With Sample and Demonstration3
Medication Without Samples4
Medication With Sample and Demonstration2
Medication Without Samples3
Medication Without Samples2

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Change in Acne Lesion Count

Change in total count of acne lesions from baseline visit to Week 6 visit (NCT01504204)
Timeframe: Baseline and 6 weeks

,
Interventionlesions (Mean)
Basleine (Inflammatory Lesions)Baseline (Non-Inflammatory)Week 6 (inflammatory Lesion)Week 6 (Non-inflammatory Lesion)
Medication With Sample and Demonstration333119
Medication Without Samples238135

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Adherence to Study Medication

Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap. (NCT01504204)
Timeframe: Baseline to 6 weeks

Interventionpercentage of doses (Median)
Medication With Sample and Demonstration86
Medication Without Samples71

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Clinical Success on Investigator's Global Evaluation

"Percentage of subjects with a clinical response of success, defined as an IGA score that is at least 2 grades less than the baseline assessment." (NCT01796665)
Timeframe: Baseline to week 12

InterventionParticipants (Count of Participants)
Test Product103
Reference Product120
Placebo Product23

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Mean Percent Change in the Inflammatory (Papules and Pustules) Lesion Count

Per protocol population (NCT01796665)
Timeframe: Baseline to week 12

Interventionpercent change of lesion counts (Mean)
Test Product61.70
Reference Product63.89
Placebo Product42.22

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Mean Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Count

(NCT01796665)
Timeframe: Baseline to week 12

Interventionpercent change of lesion counts (Mean)
Test Product51.57
Reference Product51.59
Placebo Product33.33

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Local Tolerability (Stinging/Burning)

Highest Severity of Local Tolerability Scores Worse Than Baseline (NCT01910064)
Timeframe: 12 months

Interventionsubjects (Number)
MildModerateSevere
GK530G251799

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Local Tolerability (Dryness)

Highest Severity of Local Tolerability Scores Worse Than Baseline (NCT01910064)
Timeframe: 12 months

Interventionparticipants (Number)
MildModerateSevere
GK530G254521

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Local Tolerability (Erythema)

Highest severity of Local tolerability scores worth than base line (NCT01910064)
Timeframe: 12 monhths

Interventionparticipants (Number)
MildModerateSevere
GK530G149645

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Local Tolerability (Pruritus)

Highest Severity of Local Tolerability Scores Worse Than Baseline (NCT01910064)
Timeframe: 12 months

Interventionparticipants (Number)
MildModerateSevere
GK530G149354

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Local Tolerability (Scaling)

Highest severity of Local tolerability scores worth than base line (NCT01910064)
Timeframe: 12 months

Interventionparticipants (Number)
MildModerateSevere
GK530G191602

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Percent Changes From Baseline in Total Lesion Counts

(NCT01910064)
Timeframe: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

Interventionpercent change (Median)
Week 1Week 2Week 4Month 2Month 3Month 6Month 9Month 12
GK530G25.642.152.967.174.782.083.686.2

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Inflammatory Lesions

The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

Interventionlesions (Mean)
BaselineWeek 2Week 4Week 8
Adapalene/BPO Gel/Foam Wash/Moisturizer27.317.415.714.4

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Scaling

Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline73800
Week 2571540
Week 465920
Week 863900

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Non-inflammatory Lesions

The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

Interventionlesions (Mean)
BaselineWeek 2Week 4Week 8
Adapalene/BPO Gel/Foam Wash/Moisturizer49.436.434.129.2

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Subject Questionnaire

Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

Interventionparticipants (Number)
Very satisfiedSatisfiedUndecidedDissatisfiedVery dissatisfiedMissing
Adapalene/BPO Gel/Foam Wash/Moisturizer23425313

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Stinging/Burning

Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline80100
Week 2482350
Week 4631210
Week 8621000

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Erythema

Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline502830
Week 2492070
Week 4452650
Week 8521820

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Dryness

Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

,,,
Interventionparticipants (Number)
NoneMildModerateSevere
Baseline711000
Week 2452290
Week 4561910
Week 8601110

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Total Lesion Count

The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks. (NCT01951417)
Timeframe: Baseline, 2, 4, and 8 weeks

Interventionlesions (Mean)
BaselineWeek 2Week 4Week 8
Adapalene/BPO Gel/Foam Wash/Moisturizer76.753.950.043.7

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Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count

"Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count.~Closed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed bump in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)" (NCT02005666)
Timeframe: week 11

Interventionpercentage of change (Mean)
Test-Cadila Healthcare Limited-61.7
Reference-DUAC® Gel-61.3
Placebo-42.0

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Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.

"Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count.~Papule was Inflammatory lesion; small (< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)" (NCT02005666)
Timeframe: week 11

Interventionpercentage of mean change from baseline (Mean)
Test-Cadila Healthcare Limited-67.6
Reference-DUAC® Gel-71.3
Placebo-51.9

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To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel

The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated (NCT02052752)
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

,,
InterventionUnits on a scale (Mean)
Baseline to hour 2Baseline to hour 4Baseline to day 1Baseline to day 2Baseline to day 4
Positive Control0.00.0-0.3-0.7-1.0
Test Product0.00.0-0.2-0.8-1.2
Vehicle Gel0.00.0-0.2-0.5-0.7

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To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.

The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe. (NCT02052752)
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

,,
InterventionUnits on a scale (Mean)
Change from baseline to hour 2Change from baseline to hour 4Change from baseline to day 1Change from baseline to day 2Change from baseline to day 4
Positive Control-0.03-0.10-0.73-1.36-1.84
Test Product-0.04-0.12-0.62-1.26-1.83
Vehicle Gel-0.02-0.06-0.56-1.02-1.39

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To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.

The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant (NCT02052752)
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4

,,
InterventionPercentage change (Mean)
From baseline to hour 2From baseline to hour 4From baseline to day 1From baseline to day 2From baseline to day 4
Positive Control-4.57-5.94-20.22-42.94-52.57
Test Product-3.24-6.02-21.42-40.30-57.22
Vehicle Gel-4.65-7.01-22.07-37.03-48.60

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To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.

The Investigator assessed and score each target lesion's diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion's widest or highest points. (NCT02052752)
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

,,
InterventionPercentage change (Mean)
From baseline to hour 2From baseline to hour 4From baseline to day 1From baseline to day 2From baseline to day 4
Positive Control-0.33-0.63-11.93-37.83-44.78
Test Product-0.46-0.74-12.46-30.98-52.56
Vehicle Gel-1.33-0.22-12.83-29.81-38.78

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To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel

The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated. (NCT02052752)
Timeframe: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4

,,
InterventionUnits on a scale (Mean)
Change from baseline to hour 2Change from baseline to hour 4Change from baseline to day 1Change from baseline to day 2Change from baseline to day 4
Positive Control0.30.40.40.70.8
Test Product0.30.40.30.50.9
Vehicle Gel0.10.30.30.60.8

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To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.

The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure (NCT02052752)
Timeframe: Baseline to Day 4

InterventionPercentage change (Mean)
Test Product-57.42
Vehicle Gel-47.89
Positive Control-53.07

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Percent Changes From Baseline in Total Lesion Counts

(NCT02073448)
Timeframe: Baseline - Week12

Interventionpercent change (Median)
CD027168.6
GK530G82.7
CD157981.6

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Percent of Subjects With Adverse Events

(NCT02073448)
Timeframe: up to 12 weeks

Interventionpercentage of participants (Number)
CD027127.7
GK530G44.8
CD157937.5

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Local Tolerability (Dryness)

Highest severity of local tolerability scores worse than Baseline (NCT02073448)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD02714461
CD15792940
GK530G113311

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Local Tolerability (Erythema)

Highest severity of local tolerability scores worse than Baseline (NCT02073448)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD02713250
CD15792041
GK530G78242

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Local Tolerability (Pruritus)

Highest severity of local tolerability scores worse than Baseline (NCT02073448)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD02712420
CD15792491
GK530G61213

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Local Tolerability (Scaling)

Highest severity of local tolerability scores worse than Baseline (NCT02073448)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD02713791
CD15792430
GK530G105331

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Local Tolerability (Stinging/Burning)

Highest severity of local tolerability scores worse than Baseline (NCT02073448)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD027149112
CD15792191
GK530G106767

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Local Tolerability (Dryness)

Highest severity of local tolerability scores worse than Baseline (NCT02073461)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerate
CD1579 2.5%202
CD1579 5%336
Vehicle100

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Percent Changes From Baseline in Total Lesion Counts

Median percent reductions from Baseline in total lesion count (ITT-LOCF) (NCT02073461)
Timeframe: Baseline - Week 12

Interventionpercent change (Median)
CD1579 2.5%58.3
CD1579 5%65.9
Vehicle25.5

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Local Tolerability (Erythema)

Highest severity of local tolerability scores worse than Baseline (NCT02073461)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD1579 2.5%1230
CD1579 5%1831
Vehicle500

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Percent of Subjects With Adverse Events

Adverse events which were observed in 5% or more patients with either group are listed. (NCT02073461)
Timeframe: up to 12 weeks

,,
Interventionpercentage of participants (Number)
% of subjects with AEsNasopharyngitisHeadacheDysmenorrhea
CD1579 2.5%43.012.710.16.3
CD1579 5%39.714.11.33.8
Vehicle32.913.98.93.8

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Local Tolerability (Stinging/Burning)

Highest severity of local tolerability scores worse than Baseline (NCT02073461)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerate
CD1579 2.5%196
CD1579 5%297
Vehicle41

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Local Tolerability (Scaling)

Highest severity of local tolerability scores worse than Baseline (NCT02073461)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerate
CD1579 2.5%154
CD1579 5%257
Vehicle81

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Local Tolerability (Pruritus)

Highest severity of local tolerability scores worse than Baseline (NCT02073461)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
MildModerateSevere
CD1579 2.5%2061
CD1579 5%1372
Vehicle610

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Percent Change From Baseline in Non-inflammatory Lesion Count

(NCT02249104)
Timeframe: Baseline and 8 weeks

InterventionPercent change (Mean)
Acne Treatment-27.1

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Percent Change From Baseline in Inflammatory Lesion Count

(NCT02249104)
Timeframe: Baseline and 8 weeks

InterventionPercent change (Mean)
Acne Treatment-35.7

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Mean Change From Baseline in Total Lesion Count

(NCT02249104)
Timeframe: Baseline and 8 weeks

InterventionLesions counted (Mean)
Acne Treatment-26.9

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Mean Change From Baseline in Non-inflammatory Lesion Count

(NCT02249104)
Timeframe: Baseline and 8 weeks

InterventionLesions counted (Mean)
Acne Treatment-16.3

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Mean Change From Baseline in Inflammatory Lesion Count

(NCT02249104)
Timeframe: Baseline and 8 weeks

InterventionLesions counted (Mean)
Acne Treatment-10.8

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Percent Change From Baseline in Total Lesion Count

(NCT02249104)
Timeframe: Baseline and 8 weeks

InterventionPercent change (Mean)
Acne Treatment-29.6

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Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)

The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated. (NCT02465632)
Timeframe: Baseline and 10 Weeks

Interventionpercentage change from baseline (Mean)
Test72.3
Reference71.1
Placebo39.1

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Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)

The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated. (NCT02465632)
Timeframe: Baseline and 10 Weeks

InterventionPercentage change from baseline (Mean)
Test64.5
Reference63.3
Placebo30.9

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Surgical Site Infection That Requires Antibiotics

Cultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature. (NCT02510144)
Timeframe: At one year

InterventionParticipants (Count of Participants)
Chlorhexidine0
Benzoyl Peroxide0

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Skin Swab and Culture With Colony Forming Units (CFUs)

Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla. (NCT02510144)
Timeframe: At time of surgery

,
Interventionnegative skin cultures (Number)
InterventionControl
Benzoyl Peroxide5122
Chlorhexidine3935

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Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions

(NCT02515305)
Timeframe: Baseline to Day 84

Interventionpercentage of lesion change (Mean)
Test Product58.99
Reference Product58.93
Placebo Product32.25

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Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions

(NCT02515305)
Timeframe: Baseline to Day 84

Interventionpercentage of lesion change (Mean)
Test Product71.05
Reference Product72.84
Placebo Product51.53

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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.

Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1. (NCT02524665)
Timeframe: Baseline and Week 1, 2, 4, 8

,
InterventionScore on a scale (Mean)
Erythema score-Week 1Erythema score -Week 2Erythema score -Week 4Erythema score -Week 8Dryness score-Week 1Dryness score -Week 2Dryness score -Week 4Dryness score -Week 8Peeling score-Week 1Peeling score -Week 2Peeling score -Week 4Peeling score -Week 8
MAXCLARITY II0.16-0.21-0.37-0.320.11-0.11-0.050.000.05-0.11-0.05-0.11
Murad0.00-0.16-0.32-0.320.00-0.11-0.050.05-0.11-0.11-0.05-0.05

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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.

Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1. (NCT02524665)
Timeframe: Baseline and Week 1, 2, 4, 8

,
InterventionScore on a scale (Mean)
Redness score-Week 1Redness score -Week 2Redness score -Week 4Redness score -Week 8Dryness score-Week 1Dryness score -Week 2Dryness score -Week 4Dryness score -Week 8Burning score-Week 1Burning score -Week 2Burning score -Week 4Burning score -Week 8Itching score-Week 1Itching score -Week 2Itching score -Week 4Itching score -Week 8Scaling score-Week 1Scaling score -Week 2Scaling score -Week 4Scaling score -Week 8
MAXCLARITY II-0.11-0.11-0.32-0.42-0.21-0.16-0.37-0.420.11-0.11-0.26-0.26-0.210.00-0.26-0.210.05-0.26-0.160.11
Murad-0.32-0.26-0.11-0.26-0.11-0.26-0.11-0.110.160.00-0.050.000.000.110.110.11-0.11-0.260.110.21

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Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8

During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1. (NCT02524665)
Timeframe: Baseline and Week 1, 2, 4, 8

,
InterventionScore on a scale (Mean)
ISGA score-Week 1ISGA score -Week 2ISGA score -Week 4ISGA score -Week 8
MAXCLARITY II-0.05-0.16-0.47-1.16
Murad-0.11-0.05-0.58-0.89

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Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.

During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1. (NCT02524665)
Timeframe: Baseline and Week 1, 2, 4

,
InterventionPercent change (Mean)
Inflammatory lesion counts- Week 1, n=19, 17Inflammatory lesion counts- Week 2, n=19, 17Inflammatory lesion counts- Week 4, n=19, 17Non-inflammatory lesion counts- Week 1, n=19, 19Non-inflammatory lesion counts- Week 2, n=19, 19Non-inflammatory lesion counts- Week 4, n=19, 19Total lesion counts-Week 1, n=19, 19Total lesion counts-Week 2, n=19, 19Total lesion counts-Week 4, n=19, 19
MAXCLARITY II-17.69-46.69-55.35-4.94-28.07-52.85-12.57-37.06-60.93
Murad-7.85-14.25-51.95-15.92-37.07-60.27-18.29-35.84-60.73

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Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.

During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1. (NCT02524665)
Timeframe: Baseline and Week 8

,
InterventionPercent change (Mean)
Inflammatory lesion counts- Week 8, n=19, 17Non-inflammatory lesion counts- Week 8, n=19, 19Total lesion counts-Week 8, n=19, 19
MAXCLARITY II-78.70-69.32-76.67
Murad-61.52-77.09-75.01

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Percentage of Participant Who Improved by at Least One Grade on the ISGA

During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1. (NCT02524665)
Timeframe: Up to Week 8

,
InterventionPercentage of participants (Number)
One or more grade improvement-Week 1Two or more grade improvement-Week 1One or more grade improvement-Week 2Two or more grade improvement-Week 2One or more grade improvement-Week 4Two or more grade improvement-Week 4One or more grade improvement-Week 8Two or more grade improvement-Week 8
MAXCLARITY II10.50.015.85.347.45.378.942.1
Murad10.50.010.50.057.90.068.421.1

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Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions

(NCT02525549)
Timeframe: 84 days

Interventionpercent change of lesion counts (Mean)
Test Product61.07
Reference Product65.58
Placebo Product41.63

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Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions

(NCT02525549)
Timeframe: 84 days

Interventionpercent change of lesion counts (Mean)
Test Product54.33
Reference Product55.06
Placebo Product36.40

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Number of Participants Satisfied and Very Satisfied With Regimen

Number of subjects satisfied and very satisfied with the three-part treatment regimen (NCT02589405)
Timeframe: 12 weeks

Interventionparticipants (Number)
Treatment Regimen42

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Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts

Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population. (NCT02616614)
Timeframe: 12 weeks

Interventionpercentage of change (Mean)
Generic Clindamycin and Benzoyl Peroxide-63.81
Reference Onexton (Clindamycin and Benzoyl Peroxide)-67.56
Vehicle Gel-53.78

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Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts

One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population. (NCT02616614)
Timeframe: 12 weeks

Interventionpercentage of change (Mean)
Generic Clindamycin and Benzoyl Peroxide-49.58
Reference Onexton (Clindamycin and Benzoyl Peroxide)-49.50
Vehicle Gel-37.50

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Number of Subjects With Treatment Success at Week 12

"The secondary efficacy endpoint was the IGA score, expressed in terms of proportion of subjects with treatment success or failure at Week 12, where success was defined as an IGA score that was at least 2 grades less than the baseline assessment." (NCT02616614)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
SuccessFailure
Generic Clindamycin and Benzoyl Peroxide54199
Reference Onexton (Clindamycin and Benzoyl Peroxide)60195
Vehicle Gel13109

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"Percentage of Patients With a Clinical Response of Clinical Success Using the Investigator's Global Assessment (IGA) at Week 12"

"The Investigator's Global Assessment had to show a score of 0 (clear) or 1 (almost clear) to be considered a Clinical Success.~0= Clear skin with no inflammatory or non inflammatory lesions.~Almost clear, rare non-inflammatory lesions with no more than one small inflammatory lesion.~Mild severity; greater than Grade 1; some non inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions).~Moderate severity; greater than Grade 2; up to many non inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.~Severe; greater than Grade 3, up to many non inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions.~Very severe, greater than Grade 4" (NCT02651220)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w112
Epiduo® Forte Gel 0.3%/2.5% w/w106
Vehicle Topical Gel15

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Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.

(NCT02651220)
Timeframe: 12 weeks

Interventionpercentage of change from baseline (Mean)
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w-74.2
Epiduo® Forte Gel 0.3%/2.5% w/w-73.0
Vehicle Topical Gel-30.6

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Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.

(NCT02651220)
Timeframe: 12 weeks

Interventionpercentage of change from baseline (Mean)
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w-65.4
Epiduo® Forte Gel 0.3%/2.5% w/w-64.5
Vehicle Topical Gel-25.5

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Investigator Global Acne Assessment - Week 1

"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present." (NCT02698436)
Timeframe: 1 Week

InterventionScore on a scale (Mean)
Acne Mask2.35
2.5% Benzoyl Peroxide2.34

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Investigator Global Acne Assessment - Baseline

"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present." (NCT02698436)
Timeframe: Baseline

InterventionScore on a scale (Mean)
Acne Mask2.55
2.5% Benzoyl Peroxide2.51

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Acne Lesion Counts Total Global Face - Week 8

Acne Lesion Count Total Global Face Week 8 (NCT02698436)
Timeframe: 8 Weeks

InterventionLesion Count (Mean)
Acne Mask27.8
2.5% Benzoyl Peroxide26.4

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Acne Lesion Counts Total Global Face - Week 4

Acne Lesion Count Total Global Face Week 4 (NCT02698436)
Timeframe: 4 Weeks

InterventionLesion Count (Mean)
Acne Mask30.5
2.5% Benzoyl Peroxide27.0

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Acne Lesion Counts Total Global Face - Week 2

Acne Lesion Count Total Global Face Week 2 (NCT02698436)
Timeframe: 2 Weeks

InterventionLesion Count (Mean)
Acne Mask35.3
2.5% Benzoyl Peroxide30.5

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Acne Lesion Counts Total Global Face - Week 12

Acne Lesion Count Total Global Face Week 12 (NCT02698436)
Timeframe: 12 Weeks

InterventionLesion Count (Mean)
Acne Mask24.8
2.5% Benzoyl Peroxide23.3

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Acne Lesion Counts Total Global Face - Week 1

Acne Lesion Count Total Global Face Week 1 (NCT02698436)
Timeframe: 1 Week

InterventionLesion Count (Mean)
Acne Mask39.2
2.5% Benzoyl Peroxide36.8

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Acne Lesion Counts Total Global Face - Baseline

Acne Lesion Count Total Global Face at Baseline (NCT02698436)
Timeframe: Baseline

InterventionLesion Count (Mean)
Acne Mask47.2
2.5% Benzoyl Peroxide47.6

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Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8

(NCT02698436)
Timeframe: Baseline to 8 Weeks

InterventionPercent change of acne lesion count (Mean)
Acne Mask-40
2.5% Benzoyl Peroxide-50

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Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4

(NCT02698436)
Timeframe: Baseline to 4 Weeks

InterventionPercent change of acne lesion count (Mean)
Acne Mask-35
2.5% Benzoyl Peroxide-46

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Investigator Global Acne Assessment - Week 12

"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present." (NCT02698436)
Timeframe: 12 Weeks

InterventionScore on a scale (Mean)
Acne Mask1.77
2.5% Benzoyl Peroxide1.59

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Investigator Global Acne Assessment - Week 4

"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present." (NCT02698436)
Timeframe: 4 Weeks

InterventionScore on a scale (Mean)
Acne Mask2.08
2.5% Benzoyl Peroxide1.87

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Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1

(NCT02698436)
Timeframe: Baseline to 1 Week

InterventionPercent change of acne lesion count (Mean)
Acne Mask-19
2.5% Benzoyl Peroxide-26

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Percent Change of Global Face Total Acne Lesion Count From Baseline

(NCT02698436)
Timeframe: Baseline to 12 Weeks

InterventionPercent change of acne lesion count (Mean)
Acne Mask-44
2.5% Benzoyl Peroxide-54

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Investigator Global Acne Assessment - Week 8

"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present." (NCT02698436)
Timeframe: 8 Weeks

InterventionScore on a scale (Mean)
Acne Mask1.88
2.5% Benzoyl Peroxide1.70

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Investigator Global Acne Assessment - Week 2

"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present." (NCT02698436)
Timeframe: 2 Weeks

InterventionScore on a scale (Mean)
Acne Mask2.23
2.5% Benzoyl Peroxide2.11

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Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2

(NCT02698436)
Timeframe: Baseline to 2 Weeks

InterventionPercent change of acne lesion count (Mean)
Acne Mask-28
2.5% Benzoyl Peroxide-42

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Percent Change From Baseline in Non-Inflammatory Lesion Count

Percent Change From Baseline in Non-Inflammatory Lesion Count. (NCT02899000)
Timeframe: Weeks 4, 8, and 12

Interventionpercent change in lesions (Mean)
Week 4Week 8Week 12
Acne Treatment-34.6-50.2-58.7

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Percent Change From Baseline in Inflammatory Lesion Count

Percent Change From Baseline in Inflammatory Lesion Count. (NCT02899000)
Timeframe: Weeks 4, 8, and 12

Interventionpercent change in lesions (Mean)
Week 4Week 8Week 12
Acne Treatment-38.5-55.0-66.2

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Number and Percent of Subjects With IGA Success

IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1) (NCT02899000)
Timeframe: Weeks 4, 8, and 12

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12
Acne Treatment94469

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Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates

"At each visit, subjects were evaluated by the investigator to determine whether (in the opinion of the investigator) they would consider them as candidates for oral isotretinoin therapy.~The outcome measure reports the number and % of subjects who, in the opinion of the investigator, were not considered to be a candidate for oral isotretinoin therapy." (NCT02899000)
Timeframe: Weeks 0, 4, 8, and 12

InterventionParticipants (Count of Participants)
Week 0Week 4Week 8Week 12
Acne Treatment078121149

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Change From Baseline in Total Lesion Count

Change From Baseline in Total Lesion Count. (NCT02899000)
Timeframe: Weeks 4, 8, and 12

Interventionchange in lesions (Mean)
Week 4Week 8Week 12
Acne Treatment-43.7-59.4-69.2

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Change From Baseline in Non-Inflammatory Lesion Count

Change From Baseline in Non-Inflammatory Lesion Count. (NCT02899000)
Timeframe: Weeks 4, 8, and 12

Interventionchange in lesions (Mean)
Week 4Week 8Week 12
Acne Treatment-24.9-33.6-39.1

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Change From Baseline in Inflammatory Lesion Count

Change From Baseline in Inflammatory Lesion Count. (NCT02899000)
Timeframe: Weeks 4, 8, and 12

Interventionchange in lesions (Mean)
Week 4Week 8Week 12
Acne Treatment-18.9-25.9-30.1

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Subject Assessment of Acne Improvement

Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse). (NCT02899000)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Acne Treatment1.3

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Change in Number of Inflammatory Lesions

Change in Number of Inflammatory Lesions from baseline. (NCT02899000)
Timeframe: Week 12

InterventionInflammatory lesions (Mean)
Acne Treatment-30.1

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Number and Percent of Adverse Events

Number and percent of subjects with any Treatment-Related Adverse Event (NCT02899000)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Acne Treatment27

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Percent Change From Baseline in Total Lesion Count

Percent Change From Baseline in Total Lesion Count. (NCT02899000)
Timeframe: Weeks 4, 8, and 12

Interventionpercent change in lesions (Mean)
Week 4Week 8Week 12
Acne Treatment-38.9-53.9-62.6

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Adverse Event Severity

Safety/drug-tolerance evaluated by subject-reported adverse events as well as physician evaluated erythema, scaling, drying, and stinging/burning on a 0-3 point scale, where 0=none and 3=severe. (NCT03122457)
Timeframe: Day 99

InterventionParticipants (Count of Participants)
0123
Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo22000

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PGA Score

Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy (NCT03122457)
Timeframe: Day 99

Interventionscore on a scale (Mean)
Lidamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combo0.53

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Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms

Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms. (NCT03257202)
Timeframe: 21 days

Interventionparticipants (Number)
Negative Control10
Benzoyl Peroxide 5% Topical Gel12
Clindamycin 1% Topical Gel10
Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel10

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Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count

Per protocol population (NCT03393494)
Timeframe: Day 1 to week 12

Interventionpercentage of lesion change (Mean)
Perrigo Active62.75
Reference Active60.78
Perrigo Placebo43.45

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Mean Percent Change From Baseline in the Papules and Pustules Lesion Count

(NCT03393494)
Timeframe: Day 1 to week 12

Interventionpercentage of lesion change (Mean)
Perrigo Active68.18
Reference Active63.56
Perrigo Placebo50.72

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Change From Baseline in Inflammatory Lesion Counts at Week 12

Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03448939)
Timeframe: Baseline, Week 12

InterventionInflammatory Lesions (Least Squares Mean)
S5G4T-1-17.4
S5G4T-2 Vehicle Cream-9.5

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Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03448939)
Timeframe: Baseline, Week 12

InterventionPercent Change (Least Squares Mean)
S5G4T-1-68.2
S5G4T-2 Vehicle Cream-38.3

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Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12

"Percentage of participants in each treatment group achieving an acne severity IGA score of clear (score=0) or almost clear (score=1)." (NCT03448939)
Timeframe: Baseline through Week 12

InterventionPercentage of Participants (Number)
S5G4T-143.5
S5G4T-2 Vehicle Cream16.1

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Non-inflammatory Lesion Count

Non-inflammatory lesions here include open and closed comedones. These are counted on the face by the investigator from edge of hairline to mandibular line and lower count indicates less severe disease. (NCT03457636)
Timeframe: Baseline, Week 4, Week 8, Week 12

Interventionlesion count (Median)
BaselineWeek 4Week 8Week 12
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide3327179

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IGA Score

The percent of subjects who have at least a 2 grade improvement on IGA score (NCT03457636)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide19

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Investigator Global Assessment (IGA) Score

The IGA is an assessment by the Investigator to assess the severity of the subject's disease wherein 0=Clear Skin, 1=Almost Clear, 2=Mild Severity, 3=Moderate, 4=Severe, 5=Very Severe. Lower score indicate less severe disease. (NCT03457636)
Timeframe: Baseline, Week 4, Week 8, Week 12

InterventionParticipants (Count of Participants)
Baseline72475436Week 472475436Week 872475436Week 1272475436
Almost ClearClearSevereModerateMild
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide20
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide0
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide5
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide15
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide2
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide10
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide8
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide6
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide1
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide13

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Inflammatory Lesion Count

Inflammatory lesions here include papules and pustules on the face from edge of hairline to mandibular line as counted by the Investigator. Lower counts indicate less severe disease. (NCT03457636)
Timeframe: Baseline, Week 4, Week 8, Week 12

Interventioncount of lesions (Median)
BaselineWeek 4Week 8Week 12
Doxycycline Anhydrous and Adapalene/Benzoyl Peroxide3321126

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Change From Baseline in Inflammatory Lesion Counts at Week 12

Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03564119)
Timeframe: Baseline, Week 12

InterventionInflammatory Lesions (Least Squares Mean)
S5G4T-1-20.3
S5G4T-2 Vehicle Cream-13.3

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Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12

"Percentage of participants in each treatment group achieving an acne severity IGA score of clear (score=0) or almost clear (score=1). Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation." (NCT03564119)
Timeframe: Baseline through Week 12

InterventionPercentage of Participants (Number)
S5G4T-150.1
S5G4T-2 Vehicle Cream25.9

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Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an ANCOVA with factors of treatment and analysis center and Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03564119)
Timeframe: Baseline, Week 12

InterventionPercent Change (Least Squares Mean)
S5G4T-1-69.4
S5G4T-2 Vehicle Cream-46.0

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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (non-serious) regardless of causality is located in 'Reported Adverse Events' Section. (NCT03564145)
Timeframe: Baseline up to Week 52

InterventionParticipants (Count of Participants)
AEsSAEs
S5G4T-118510

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Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 12

InterventionNon-Inflammatory Lesions (Least Squares Mean)
S6G5T-3-29.7
S6G5T-8 Vehicle Cream-19.8

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Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face

"Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 (not embarrassed at all) to 10 (extremely embarrassed)." (NCT03761784)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
S6G5T-342.8
S6G5T-8 Vehicle Cream32.7

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Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)

"Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 (no pimples at all) to 10 (pimples as bad as you can imagine)." (NCT03761784)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
S6G5T-338.9
S6G5T-8 Vehicle Cream18.6

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Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 12

InterventionInflammatory Lesions (Least Squares Mean)
S6G5T-3-21.6
S6G5T-8 Vehicle Cream-14.8

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Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 4

InterventionInflammatory Lesions (Least Squares Mean)
S6G5T-3-13.5
S6G5T-8 Vehicle Cream-9.8

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Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 8

InterventionInflammatory Lesions (Least Squares Mean)
S6G5T-3-17.2
S6G5T-8 Vehicle Cream-12.5

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Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 4

InterventionNon-Inflammatory Lesions (Least Squares Mean)
S6G5T-3-18.5
S6G5T-8 Vehicle Cream-13.4

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Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 8

InterventionNon-Inflammatory Lesions (Least Squares Mean)
S6G5T-3-24.4
S6G5T-8 Vehicle Cream-16.9

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Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 12

InterventionPercent Change (Least Squares Mean)
S6G5T-3-66.1
S6G5T-8 Vehicle Cream-43.5

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Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761784)
Timeframe: Baseline, Week 12

InterventionPercent Change (Least Squares Mean)
S6G5T-3-61.6
S6G5T-8 Vehicle Cream-40.9

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Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline

"Percentage of participants in each treatment group achieving an acne severity IGA score of clear (score=0) or almost clear (score=1) and achieving an acne severity IGA score of at least 2 grades less than Baseline." (NCT03761784)
Timeframe: Baseline through Week 12

Interventionpercentage of participants (Number)
S6G5T-338.5
S6G5T-8 Vehicle Cream11.5

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Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 12

InterventionInflammatory Lesions (Least Squares Mean)
S6G5T-3-16.2
S6G5T-8 Vehicle Cream-14.1

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Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 4

InterventionInflammatory Lesions (Least Squares Mean)
S6G5T-3-10.7
S6G5T-8 Vehicle Cream-10.1

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Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 8

InterventionInflammatory Lesions (Least Squares Mean)
S6G5T-3-14.0
S6G5T-8 Vehicle Cream-12.5

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Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 12

InterventionNon-Inflammatory Lesions (Least Squares Mean)
S6G5T-3-24.2
S6G5T-8 Vehicle Cream-17.4

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Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 8

InterventionNon-Inflammatory Lesions (Least Squares Mean)
S6G5T-3-20.0
S6G5T-8 Vehicle Cream-12.8

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Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 12

InterventionPercent Change (Least Squares Mean)
S6G5T-3-57.6
S6G5T-8 Vehicle Cream-50.8

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Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 12

InterventionPercent Change (Least Squares Mean)
S6G5T-3-54.4
S6G5T-8 Vehicle Cream-41.5

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Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline

"Percentage of participants in each treatment group achieving an acne severity IGA score of clear (score=0) or almost clear (score=1) and achieving an acne severity IGA score of at least 2 grades less than Baseline." (NCT03761810)
Timeframe: Baseline through Week 12

Interventionpercentage of participants (Number)
S6G5T-325.4
S6G5T-8 Vehicle Cream14.7

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Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face

"Percent of participants in each treatment group achieving at least a 4 point reduction on Item 5 (Embarrassment) of the patient reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst, in the 24 hours prior to administration on an 11-point NRS ranging from 0 (not embarrassed at all) to 10 (extremely embarrassed)." (NCT03761810)
Timeframe: Baseline and Week 12

InterventionPercentage of Participants (Number)
S6G5T-333.9
S6G5T-8 Vehicle Cream37.1

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Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline. (NCT03761810)
Timeframe: Baseline, Week 4

InterventionNon-Inflammatory Lesions (Least Squares Mean)
S6G5T-3-14.6
S6G5T-8 Vehicle Cream-10.8

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Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)

"Percent of participants in each treatment group achieving at least a 4 point reduction on Item 1 (Pimple) of the patient- reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 (no pimples at all) to 10 (pimples as bad as you can imagine)." (NCT03761810)
Timeframe: Baseline and Week 12

InterventionPercentage of Participants (Number)
S6G5T-335.1
S6G5T-8 Vehicle Cream27.2

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Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate

"This outcome measures the load of Propionibacteria on the skin and incision of participants in the operating room prior to shoulder arthroplasty when patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. The Propionibacteria load was quantified based on the growth of bacteria on the agar plate using a quadrant system. Quantitative specimen Propionibacteria values (SpCuVs) were assigned as following: no growth= 0, broth only= 0.1, one colony only= 0.1, and 1 quadrant growth = 1, 2 quadrant growth = 2, 3 quadrant growth = 3, and 4 quadrant growth = 4. Samples were taken on the day of surgery and the cultures were held for 21 days." (NCT04021524)
Timeframe: Day of Surgery

,
InterventionSpCuV (Mean)
Skin Surface SpCuVDermal Edge SpCuV
BPO Soap1.50.8
Hibiclens Soap1.60.8

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Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate

Patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. On the day of surgery the patients' skin and incisions were swabbed in the operating room prior to shoulder arthroplasty. Specimens were held for 21 days. (NCT04021524)
Timeframe: Day of Surgery

,
InterventionParticipants (Count of Participants)
Skin Surface Positive SwabDermal Edge Positive Swab
BPO Soap2411
Hibiclens Soap2514

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Median Colony Forming Units Per mL Treatment vs Control

Samples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides. (NCT04300010)
Timeframe: up to 2 days

,,
InterventionCFU/mL (Median)
Treatment plus CHX ArmControl Arm after CHX
5% Topical Benzoyl Peroxide Gel200041500
Blue Light Therapy50000108000
Light and Gel200020000

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Percentage of Participants in Each Group With Positive C. Acnes Cultures

Comparison of positive Cutibacterium acnes cultures as a binary (yes/no) outcome between treatment arm and control arm following chlorhexidine (CHX) prep. Reported is the percentage of people in each group that had Cutibacterium acnes growth. (NCT04300010)
Timeframe: up to 2 days

,,
Interventionpercent (Number)
Treatment plus CHX ArmControl Arm after CHX
5% Topical Benzoyl Peroxide Gel15.085.0
Blue Light Therapy90.080.0
Light and Gel40.070.0

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Median Colony Forming Units (CFU) After Treatment

Quantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition). (NCT04300010)
Timeframe: up to 2 days

InterventionCFU/mL (Median)
Blue Light Therapy304000
5% Topical Benzoyl Peroxide Gel28500
Light and Gel12100

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Number of Participants With C. Acnes Bacterium Culture After Treatment

Swab will be taken from skin and cultured for approximately 7 days to determine bacteria growth. This result is for the null condition following treatment with either blue light, blue light plus benzoyl peroxide or just benzoyl peroxide but before additional preparation with chlorhexidine. (NCT04300010)
Timeframe: up to 2 days

InterventionParticipants (Count of Participants)
Blue Light Therapy20
5% Topical Benzoyl Peroxide Gel20
Light and Gel16

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Inflammatory Score

changes in inflammatory score. Minimum score is 0, maximum score is 144. Higher score indicates presence of more inflammation. (NCT05096312)
Timeframe: upon enrollment, at 4 weeks, at 8 weeks

,
Interventionscore on a scale (Median)
Initial4 weeks8 weeks
Placebo Group48.547.522.67
Zinc Gluconate Group7022.678.34

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Global Acne Grading System Score

changes in Global Acne Grading System (GAGS) score. Minimum score is 0, maximum score is 44. Cut off scores are as follows: no lesion (0), mild (1-18), moderate (19-30), severe (31-38), and very severe (≥39) (NCT05096312)
Timeframe: upon enrollment, at 4 weeks, at 8 weeks

,
Interventionscore on a scale (Median)
Initial4 weeks8 weeks
Placebo Group30.3327.521.67
Zinc Gluconate Group3221.6714.34

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