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calcipotriene

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Description

calcipotriene: a topical dermatologic for the treatment of moderate plaque psoriasis; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

calcipotriol hydrate : A hydrate that is the monohydrate form of calcipotriol. It is used in combination with betamethasone dipropionate, a corticosteroid, for the topical treatment of plaque psoriasis in adult patients. [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]

Cross-References

ID SourceID
PubMed CID49800068
CHEBI ID90861
SCHEMBL ID465450
MeSH IDM0155262
PubMed CID5288783
CHEMBL ID1200666
CHEBI ID50749
SCHEMBL ID2853
MeSH IDM0155262

Synonyms (129)

Synonym
HY-10001A
calcipotriol (monohydrate)
calcipotriene
dovonex (tn)
calcipotriene hydrate
calcipotriol hydrate
calcipotriene monohydrate
D10198
calcipotriol hydrate (jan)
s7499tyy6g ,
unii-s7499tyy6g
CS-0812
calcipotriene hydrate component of taclonex
9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1.alpha.,3.beta.,5z,7e,22e,24s)-, monohydrate
taclonex component calcipotriene hydrate
calcipotriol monohydrate [who-dd]
calcipotriol hydrate [jan]
calcipotriene monohydrate [usp monograph]
calcipotriol monohydrate [ep monograph]
mc-903 hydrate
enstilar component calcipotriene hydrate
calcipotriene hydrate component of enstilar
calcipotriene hydrate [orange book]
CHEBI:90861
(1s,3r,5z,7e,22e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol hydrate
SCHEMBL465450
AKOS025312514
calcipotriol hydrate, >=98% (hplc)
Q27162836
A902099
(1r,3s,5z)-5-[(2e)-2-[(1r,3as,7ar)-1-[(1r,2e,4s)-4-cyclopropyl-4-hydroxy-1-methyl-2-buten-1-yl]octahydro-7a-methyl-4h-inden-4-ylidene]ethylidene]-4-methylene-1,3-cyclohexanediol monohydrate
MS-27664
(1r,3s,5z)-5-[(2e)-2-[(1r,3as,7ar)-1-[(e,2r,5s)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol;hydrate
calcipotriol (hydrate)
(1R,3S,Z)-5-(2-((1R,3AS,7AR,E)-1-((2R,5S,E)-5-CYCLOPROPYL-5-HYDROXYPENT-3-EN-2-YL)-7A-METHYLOCTAHYDRO-4H-INDEN-4-YLIDENE)ETHYLIDENE)-4-METHYLENECYCLOHEXANE-1,3-DIOL HYDRATE
EX-A4430A
LMST03020106
(22e)-(24s)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrovitamin d3 / (22e)-(24s)-1alpha,24-dihydroxy-26,27-cyclo-22,23-didehydrocholecalciferol / calcipotriol
(5z,7e,22e)-(1s,3r,24s)-26,27-cyclo-9,10-seco-5,7,10(19),22-cholestatetraene-1,3,24-triol
mc 903
calcipotriene [usan]
(5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1alpha,3beta,24-triol
9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5z,7e,22e)-
9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1alpha,3beta,5z,7e,22e,24s)-
ccris 7700
1,24(oh)2-22-ene-24-cyclopropyl d3
HY-10001
HMS3269P03
AB00698343-05
gtpl2778
stf-115469
divonex
mc-903
daivonex
bms-181161
u-0267
psorcutan
sorilux
dovonex
CHEBI:50749 ,
calcipotriol ,
MLS001424130
MLS000759467
smr000466353
DB02300
cpd000466353
calcipotriene (usp)
calcipotriol (jan)
D01125
NCGC00167465-01
mc903
HMS2051N11
HMS2089J08
pri-2201
CHEMBL1200666
calciptriol
calcipotriol anhydrous
(1r,3s,5z)-5-[(2e)-2-[(1r,3as,7ar)-1-[(e,2r,5s)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
dtxcid8026648
dtxsid0046648 ,
S3739
CCG-100949
pri 2201
unii-143nq3779b
calcipotriol [inn]
calcitrene
143nq3779b ,
bdbm50369964
EPITOPE ID:114242
1S19
CS-0387
AKOS015855239
calcipotriene [orange book]
calcipotriol [ep monograph]
calcipotriol [mart.]
calcipotriene [vandf]
calcipotriene [mi]
calcipotriol [who-dd]
calcipotriene [usp monograph]
calcipotriene [usp-rs]
calcipotriol [jan]
9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol, 24-cyclopropyl-, (1.alpha.,3.beta.,5z,7e,22e,24s)-
NC00199
SCHEMBL2853
(1?,3?,5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol
SR-01000762910-4
sr-01000762910
SR-01000762910-3
HMS3713K08
(1s,3r,5z,7e,14beta,17alpha,22e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol
HMS3677D04
LWQQLNNNIPYSNX-UROSTWAQSA-N
HMS3413D04
Q155683
AMY2864
calcipotrienemc 903
EX-A4430
AS-56390
EN300-21702588
(1r,3s,5z)-5-{2-[(1r,3as,4e,7ar)-1-[(2r,3e,5s)-5-cyclopropyl-5-hydroxypent-3-en-2-yl]-7a-methyl-octahydro-1h-inden-4-ylidene]ethylidene}-4-methylidenecyclohexane-1,3-diol
calcipotriene (usp-rs)
calcipotriolum
d05ax02
calsodore
calcipotriol (ep monograph)
(1s,3r,5z,7e,22e,24s)-26,27-cyclo-9,10-secocholesta-5,7,10,22-tetraene-1,3,24-triol
calcipotriolo
calcipotriene (usp monograph)
calcipotriol (mart.)

Research Excerpts

Toxicity

Calcipotriene foam was safe with an overall incidence of AEs similar to those experienced in the vehicle foam group. Incidence of adverse events in both treatment groups was low.

ExcerptReferenceRelevance
"Topical application of up to 50 gm of calcipotriol ointment per week was found to be an effective and safe treatment of psoriasis vulgaris."( Efficacy and safety of calcipotriol (MC 903) ointment in psoriasis vulgaris. A randomized, double-blind, right/left comparative, vehicle-controlled study.
Bazex, JA; Beylot, C; Chevrant-Breton, J; Dubertret, L; Jurgensen, HJ; Kalis, B; Meynadier, J; Perussel, M; Souteyrand, P; Wallach, D, 1992
)
0.28
"Short-term treatment with calcipotriol ointment (50 micrograms/g) used in amounts up to about 100 g/wk is moderately efficacious, well-tolerated, and safe in adult patients with various ichthyoses."( Efficacy, tolerability, and safety of calcipotriol ointment in disorders of keratinization. Results of a randomized, double-blind, vehicle-controlled, right/left comparative study.
Axelsen, MB; Esmann, J; Ibsen, HH; Kragballe, K; Sorensen, LH; Steijlen, PM; van de Kerkhof, PC, 1995
)
0.29
" A safe and convenient new treatment modality would be of value to most patients with psoriasis."( Calcipotriene ointment 0.005% for psoriasis: a safety and efficacy study. Calcipotriene Study Group.
Highton, A; Quell, J, 1995
)
0.29
" Only minor treatment-related adverse events were observed."( Calcipotriene ointment 0.005% for psoriasis: a safety and efficacy study. Calcipotriene Study Group.
Highton, A; Quell, J, 1995
)
0.29
" The drug did not have any adverse effects on the postnatal development of the offspring such as differentiation, functional development, emotionality, motor ability, learning ability or reproductive performance."( [Reproductive and developmental toxicity studies of calcipotriol (MC903): (4)--A perinatal and postnatal study in rats by subcutaneous administration].
Koike, Y; Konishi, R; Nagata, M; Ono, M; Shirakawa, K; Suzuki, T; Uchiyama, H, 1996
)
0.29
" Patients were carefully questioned and observed at each visit for adverse events."( Long-term effectiveness and safety of topical calcipotriene for psoriasis. Calcipotriene Study Group.
Cullen, SI, 1996
)
0.29
" Eight patients withdrew from the study (four defaulted, two unacceptable responses, two adverse events)."( Safety and efficacy of calcipotriol ointment (Dovonex) in treating children with psoriasis vulgaris.
Cunliffe, WJ; Darley, CR; Downes, N; Green, CM; Hutchinson, PE; Klaber, MR, 1996
)
0.29
" Therefore an effective and safe treatment modality is needed."( A pilot study to assess the safety and efficacy of topical calcipotriol treatment in childhood psoriasis.
Park, SB; Suh, DH; Youn, JI,
)
0.13
" There was no difference in the PASI, patient's and investigator's overall assessments and number of adverse events recorded by either group for both the treatment and follow-up phases."( Calcipotriol cream combined with twice weekly broad-band UVB phototherapy: a safe, effective and UVB-sparing antipsoriatric combination treatment. The Canadian Calcipotriol and UVB Study Group.
Bolduc, A; Gilbert, M; Lowson, D; Papp, K; Ramsay, CA; Schwartz, BE, 2000
)
0.31
"Calcipotriol cream + twice weekly broad-band UVB phototherapy is an effective and safe antipsoriatric treatment, resulting in fewer UVB exposures, lower cumulative irradiance and a saving of time."( Calcipotriol cream combined with twice weekly broad-band UVB phototherapy: a safe, effective and UVB-sparing antipsoriatric combination treatment. The Canadian Calcipotriol and UVB Study Group.
Bolduc, A; Gilbert, M; Lowson, D; Papp, K; Ramsay, CA; Schwartz, BE, 2000
)
0.31
" Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group."( Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial.
Chu, AC; Garcia-Diez, A; Guenther, L; Kragballe, K; Snellman, E; Springborg, J; Tegner, E; Van de Kerkhof, PC, 2002
)
0.31
" Several clinical trials have demonstrated that calcitriol, the naturally occurring and hormonally active form of vitamin D3, is effective and safe at the dose of 3 microg g(-1) for the treatment of psoriasis affecting the trunk and limbs."( Intra-individual comparison of the cutaneous safety and efficacy of calcitriol 3 microg g(-1) ointment and calcipotriol 50 microg g(-1) ointment on chronic plaque psoriasis localized in facial, hairline, retroauricular or flexural areas.
Czernielewski, J; Dubertret, L; Humbert, P; Janin, A; Lahfa, M; Nicolas, JF; Ortonne, JP; Tonev, SD; Tsankov, N, 2003
)
0.32
" Adverse events were more common in the calcipotriol group than in the clobetasol propionate shampoo group."( Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: a randomized comparison of efficacy and safety in subjects with scalp psoriasis.
Acebes, LO; Arsonnaud, S; Caputo, R; de Waard-van der Spek, FB; Decroix, J; Figueiredo, A; Mrowietz, U; Poncet, M; Reygagne, P, 2005
)
0.33
"The calcipotriol/betamethasone dipropionate two-compound product Dovobet/Daivobet/Taclonex(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks."( A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris.
Austad, J; Barnes, L; Bibby, A; Cambazard, F; de la Brassinne, M; Fleming, C; Heikkilä, H; Jolliffe, D; Kragballe, K; Peyri, J; Svensson, A; Toole, J; Wozel, G, 2006
)
0.33
"Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment."( A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris.
Austad, J; Barnes, L; Bibby, A; Cambazard, F; de la Brassinne, M; Fleming, C; Heikkilä, H; Jolliffe, D; Kragballe, K; Peyri, J; Svensson, A; Toole, J; Wozel, G, 2006
)
0.33
"The calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis."( Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris.
Austad, J; Barnes, L; Bibby, A; Cambazard, F; de la Brassinne, M; Fleming, C; Heikkilä, H; Kragballe, K; Peyri Rey, J; Svensson, A; Toole, J; Williams, Z; Wozel, G, 2006
)
0.33
" Safety evaluations included adverse event reporting, cutaneous safety assessed by the investigator and cutaneous discomfort assessment by the subject (both on a 5-point scale from 0: none, to 4: very severe)."( An investigator-masked comparison of the efficacy and safety of twice daily applications of calcitriol 3 microg/g ointment vs. calcipotriol 50 microg/g ointment in subjects with mild to moderate chronic plaque-type psoriasis.
Andres, P; Briantais, P; Chen, Z; Gu, J; Wang, B; Zhao, G; Zhu, X, 2007
)
0.34
" Fourteen dermatological and treatment-related adverse events were reported with calcipotriol vs."( An investigator-masked comparison of the efficacy and safety of twice daily applications of calcitriol 3 microg/g ointment vs. calcipotriol 50 microg/g ointment in subjects with mild to moderate chronic plaque-type psoriasis.
Andres, P; Briantais, P; Chen, Z; Gu, J; Wang, B; Zhao, G; Zhu, X, 2007
)
0.34
" Both treatments were safe and well tolerated."( Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial.
Andreassi, L; Ayala, F; Bongiorno, MR; Chimenti, S; Giannetti, A; Lisi, P; Martini, P; Peris, K; Peserico, A; Saraceno, R, 2007
)
0.34
"Effective and safe products are needed for long-term management of scalp psoriasis."( A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis.
Bourcier, M; Cambazard, F; Clonier, F; Gupta, G; Kidson, P; Larsen, FG; Luger, TA; Shear, NH, 2008
)
0.35
" Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2."( A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis.
Bourcier, M; Cambazard, F; Clonier, F; Gupta, G; Kidson, P; Larsen, FG; Luger, TA; Shear, NH, 2008
)
0.35
" Secondary efficacy outcomes and adverse events were also evaluated."( Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial.
Hoffmann, V; Kragballe, K; Nordin, P; Ortonne, JP; Segaert, S; Tan, J, 2009
)
0.35
" Further evidence of the superiority of the two-compound scalp formulation over the scalp solution was demonstrated through greater improvements in clinical signs and fewer adverse events."( Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial.
Hoffmann, V; Kragballe, K; Nordin, P; Ortonne, JP; Segaert, S; Tan, J, 2009
)
0.35
"High-potency topical corticosteroids are very effective for the treatment of psoriasis, but are associated with a number of cutaneous adverse effects."( Calcitriol 3 microg/g ointment: an effective and safe addition to the armamentarium in topical psoriasis therapy.
Abramovits, W, 2009
)
0.35
" Adverse event incidences were similar between patients with and without prior anti-TNF therapy."( Efficacy and safety of adalimumab in patients with psoriasis previously treated with anti-tumour necrosis factor agents: subanalysis of BELIEVE.
Chimenti, S; Gniadecki, R; Goldblum, O; Kupper, H; Ortonne, JP; Reich, K; Sprøgel, P; Thaçi, D; Unnebrink, K, 2011
)
0.37
" No adverse effects related to the study, including skin irritation, were observed or reported."( Evaluating the efficacy and safety of calcipotriene/betamethasone ointment occluded with a hydrogel patch: a 6-week bilaterally controlled, investigator-blinded trial.
Bhutani, T; Busse, KL; Koo, J; Patel, T, 2011
)
0.37
" Adverse events (AEs) were recorded throughout the study."( Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials.
Bruce, S; Brundage, T; Feldman, SR; Grande, K; Kempers, S; Markowitz, O; Matheson, R; Wyres, M, 2012
)
0.38
" Calcipotriene foam was safe with an overall incidence of AEs similar to those experienced in the vehicle foam group."( Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials.
Bruce, S; Brundage, T; Feldman, SR; Grande, K; Kempers, S; Markowitz, O; Matheson, R; Wyres, M, 2012
)
0.38
"005% foam was safe and effective for the treatment of mild to moderate plaque-type psoriasis for up to 8 weeks."( Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials.
Bruce, S; Brundage, T; Feldman, SR; Grande, K; Kempers, S; Markowitz, O; Matheson, R; Wyres, M, 2012
)
0.38
" Twenty-seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs."( Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis in adolescents 12-17 years of age.
Debarre, JM; Gooderham, M; Goodfield, M; Keddy-Grant, J; Kurvits, M; Xu, Z, 2014
)
0.4
"Narrow-band ultraviolet B (NB-UVB) is an effective and safe treatment for vitiligo."( Comparison of efficacy and safety profile of topical calcipotriol ointment in combination with NB-UVB vs. NB-UVB alone in the treatment of vitiligo: a 24-week prospective right-left comparative clinical trial.
Kanwar, AJ; Khullar, G; Parsad, D; Singh, S, 2015
)
0.42
" Calcipotriol produced mild local adverse effects."( Comparison of efficacy and safety profile of topical calcipotriol ointment in combination with NB-UVB vs. NB-UVB alone in the treatment of vitiligo: a 24-week prospective right-left comparative clinical trial.
Kanwar, AJ; Khullar, G; Parsad, D; Singh, S, 2015
)
0.42
" Sixteen patients (52%) experienced a total of 20 adverse events; 19 were considered unrelated to study treatment, 14 were mild, and none were serious or lesional or perilesional on the scalp."( Safety and efficacy of calcipotriene plus betamethasone dipropionate topical suspension in the treatment of extensive scalp psoriasis in adolescents ages 12 to 17 years.
Eichenfield, LF; Ganslandt, C; Kurvits, M; Schlessinger, J,
)
0.13
"Calcipotriol/betamethasone dipropionate combination in a non-alcoholic, lipophilic gel formulation (two-compound gel) has previously been demonstrated as a safe and effective treatment for scalp psoriasis in Caucasian, Hispanic/Latino, and Black/African American populations."( Calcipotriol plus betamethasone dipropionate gel compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized, controlled trial investigating efficacy and safety in a Chinese population.
Cui, P; Facy, P; Gao, T; Ge, M; Gu, J; Hao, F; Kurvits, M; Li, R; Ma, L; Sun, Q; Wang, G; Xu, J; Xu, Z; Yang, H; Yang, Q; Zheng, M, 2016
)
0.43
" The two-compound gel was associated with fewer adverse drug reactions than calcipotriol scalp solution (18."( Calcipotriol plus betamethasone dipropionate gel compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized, controlled trial investigating efficacy and safety in a Chinese population.
Cui, P; Facy, P; Gao, T; Ge, M; Gu, J; Hao, F; Kurvits, M; Li, R; Ma, L; Sun, Q; Wang, G; Xu, J; Xu, Z; Yang, H; Yang, Q; Zheng, M, 2016
)
0.43
" Safety was monitored by adverse events/calcium homeostasis."( Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).
Bagel, J; Leonardi, C; Olesen, M; Pariser, D; Stein Gold, L; Xu, Z; Yamauchi, P; Østerdal, ML, 2015
)
0.42
" Adverse drug reactions were reported in 10 Cal/BD foam patients (3."( Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).
Bagel, J; Leonardi, C; Olesen, M; Pariser, D; Stein Gold, L; Xu, Z; Yamauchi, P; Østerdal, ML, 2015
)
0.42
" The adverse effects (most commonly hyperpigmentation) were noted more frequently on the excimer-treated sides; however, they were well tolerated."( Comparison of effectiveness and safety of excimer lamp vs topical calcipotriol-clobetasol propionate combination in the treatment of palmoplantar psoriasis.
Bishnoi, A; Dogra, S; Narang, T; Thakur, A, 2018
)
0.48
"Psoriasis is commonly treated with topical corticosteroids, oral cytotoxic drugs and biologic agents, which can be associated with significant adverse effects (AEs), high cost and response attenuation."( Efficacy and safety of HAT1 compared with calcipotriol in the treatment of patients with mild to moderate chronic plaque psoriasis: results from an open-label randomized comparative pilot clinical study.
Alex, P; Centola, M; Sutton, C; Sutton, L; Thomas, S; Williams, S; Yesudas, T, 2020
)
0.56
" Safety response criteria included adverse drug reactions [ADRs; any adverse event (AE) possibly or probably related to treatment as determined by the investigator; a primary response criterion] and AEs (a secondary response criterion)."( Safety and efficacy of topical, fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) gel in adolescent patients with scalp and body psoriasis: a phase II trial.
Eichenfield, LF; Kurvits, M; Liljedahl, M; Marcoux, D, 2020
)
0.56
" Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort."( Safety and efficacy of fixed-dose combination calcipotriol (50 μg/g) and betamethasone dipropionate (0.5 mg/g) cutaneous foam in adolescent patients (aged 12 to <17 years) with plaque psoriasis: results of a phase II, open-label trial.
Abramovits, W; Hoejen, MN; Liljedahl, M; Seyger, M; Teng, J, 2020
)
0.56
" Cal/BD foam plus apremilast appeared to be safe and well tolerated."( Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis.
Kircik, LH; Schlesinger, TE; Tanghetti, E, 2020
)
0.56
" Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated."( Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled
Cao, S; Chen, K; Chen, Y; Cheng, H; Ding, Y; Fang, H; Han, X; He, L; He, Y; Huang, J; Li, M; Li, S; Li, W; Liu, L; Lu, Q; Lu, Y; Pan, W; Wang, J; Yan, G; Zhang, C; Zhang, J; Zheng, M; Zhu, W, 2020
)
0.56
" There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1."( Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled
Cao, S; Chen, K; Chen, Y; Cheng, H; Ding, Y; Fang, H; Han, X; He, L; He, Y; Huang, J; Li, M; Li, S; Li, W; Liu, L; Lu, Q; Lu, Y; Pan, W; Wang, J; Yan, G; Zhang, C; Zhang, J; Zheng, M; Zhu, W, 2020
)
0.56
" This superior efficacy was not associated with an increased frequency or severity of adverse events, and there was no evidence for dysregulation of the hypothalamic-pituitary-adrenal axis or calcium homeostasis."( Efficacy and safety of fixed-dose combination calcipotriol/betamethasone dipropionate foam for the treatment of psoriasis.
Paul, C; Romiti, R; Stein Gold, L, 2021
)
0.62
" Efficacy was evaluated based on primary outcome indicators including skin lesion improvement and overall adverse reaction rate."( Clinical efficacy and safety of using calcipotriol-betamethasone compounding agent for psoriasis treatment: a systematic review and meta-analysis.
Ding, H; Dong, S; Feng, J; Li, N; Li, X; Ren, J; Sun, Z; Wang, H; Wang, S; Zhu, Q, 2022
)
0.72
" There was no adverse drug reaction reported with a frequency of >1%, associated with the CAL/BDP PAD-cream."( A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis.
Augustin, M; Gold, LS; Green, LJ; Pinter, A; Praestegaard, M; Selmer, J, 2022
)
0.72
" Smartphone app images documented adverse events and mild local skin reactions, particularly erythema (75%), laser-induced swelling (28%), and crusting (27%)."( Investigating the efficacy and safety of calcipotriol/betamethasone dipropionate foam and laser microporation for psoriatic nail disease-A hybrid trial using a smartphone application, optical coherence tomography, and patient-reported outcome measures.
Bourlioux, M; Fuchs, CSK; Haedersdal, M; Mandel, VD; Nissen, CV; Ortner, VK; Philipsen, PA; Skak, K; Zibert, JR, 2022
)
0.72
" Calcipotriol did not cause adverse effects on cartilage or subchondral bone within a week, suggesting that it could be safely used in local treatment of arthritis."( No adverse effects on periarticular tissue by intra-articular vitamin D analogue calcipotriol in a reduced-dose zymosan-induced arthritis model in rats.
Finnilä, M; Huhtakangas, JA; Huovinen, J; Kauppinen, S; Laaksonen, S; Lehenkari, P; Lohela, J; Voipio, HM, 2023
)
0.91
" Overall, nine mild non-serious treatment-emergent adverse effects related to all calcipotriol formulations were reported in four subjects, but all recovered at the follow-up visit."( Efficacy and Safety of Water-Free Lipid Formulation System Containing Calcipotriol Against Psoriasis Vulgaris.
Carlsson, A; Holmback, J; Rinwa, P, 2023
)
0.91
" All adverse events were mild and deemed unrelated to treatment by the investigators."( Efficacy and Safety of Calcipotriene/Betamethasone Dipropionate Foam in the Treatment of Psoriasis in Skin of Color.
Alexis, A; Cices, A; Kaufman, B; Liu, J; Sanabria-Gonzalez, I, 2023
)
0.91
"Cal/BD foam was safe and well tolerated in plaque psoriasis patients with skin of color."( Efficacy and Safety of Calcipotriene/Betamethasone Dipropionate Foam in the Treatment of Psoriasis in Skin of Color.
Alexis, A; Cices, A; Kaufman, B; Liu, J; Sanabria-Gonzalez, I, 2023
)
0.91
"  Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms."( Efficacy, Convenience, and Safety of Calcipotriene-Betamethasone Dipropionate Cream in Skin of Color Patients With Plaque Psoriasis.
Bhatia, N; Callender, VD; Curcio, A; Feldman, SR; Gorodokin, B; Kircik, L; Kontzias, CL; Tissera, KA, 2023
)
0.91
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32

Pharmacokinetics

ExcerptReferenceRelevance
" To elucidate this difference, the pharmacokinetic profiles after a single intravenous dose (50 micrograms/kg) of the two compounds to rats were compared."( Calcipotriol (MC 903): pharmacokinetics in rats and biological activities of metabolites. A comparative study with 1,25(OH)2D3.
Binderup, L; Kissmeyer, AM, 1991
)
0.28

Compound-Compound Interactions

ExcerptReferenceRelevance
" We used low-dose narrow-band UVB phototherapy, combined with balneotherapy, short-contact anthralin, liquor carbonis detergens and calcipotriol for treatment of psoriatic patients in our day care centre."( Low-dose narrow-band UVB phototherapy combined with topical therapy is effective in psoriasis and does not inhibit systemic T-cell activation.
Bos, JD; de Rie, MA; Out, TA, 1998
)
0.3
" Subsequently, this low-dose irradiation regimen was used in combination with topical medication in 26 psoriatic patients."( Low-dose narrow-band UVB phototherapy combined with topical therapy is effective in psoriasis and does not inhibit systemic T-cell activation.
Bos, JD; de Rie, MA; Out, TA, 1998
)
0.3
"Our data indicate that low-dose narrow-band UVB can be used successfully, in combination with topical treatment, in a day care setting to treat psoriatic patients."( Low-dose narrow-band UVB phototherapy combined with topical therapy is effective in psoriasis and does not inhibit systemic T-cell activation.
Bos, JD; de Rie, MA; Out, TA, 1998
)
0.3
"Calcipotriol has been combined with a number of systemic antipsoriatric treatments, improving efficacy or reducing the systemic treatment required."( Calcipotriol cream combined with twice weekly broad-band UVB phototherapy: a safe, effective and UVB-sparing antipsoriatric combination treatment. The Canadian Calcipotriol and UVB Study Group.
Bolduc, A; Gilbert, M; Lowson, D; Papp, K; Ramsay, CA; Schwartz, BE, 2000
)
0.31
"To assess the efficacy and safety of calcipotriol cream (50 microg/g) combined with twice weekly broad-band UVB and to determine if this treatment would require fewer UVB treatments and lower cumulative UVB irradiance when compared to a standard 3 times weekly broad-band UVB regime in patients with extensive psoriasis."( Calcipotriol cream combined with twice weekly broad-band UVB phototherapy: a safe, effective and UVB-sparing antipsoriatric combination treatment. The Canadian Calcipotriol and UVB Study Group.
Bolduc, A; Gilbert, M; Lowson, D; Papp, K; Ramsay, CA; Schwartz, BE, 2000
)
0.31
" Remarkably, vitiligo lesions treated with calcipotriol initially showed delayed repigmentation compared with control areas; however, there was no therapeutic difference between calcipotriol and placebo, both in combination with UVB311 nm, by the end of the study."( Narrow-band UVB311 nm vs. broad-band UVB therapy in combination with topical calcipotriol vs. placebo in vitiligo.
Bröcker, EB; Hamm, H; Hartmann, A; Hofmann, UB; Lurz, C, 2005
)
0.33
" In this randomized and comparative study, we investigated the safety and efficacy of narrow band ultraviolet B as monotherapy and in combination with topical calcipotriol in the treatment of generalized vitiligo."( Narrow-band ultraviolet B as monotherapy and in combination with topical calcipotriol in the treatment of vitiligo.
Arca, E; Erbil, AH; Koç, E; Kurumlu, Z; Sezer, E; Taştan, HB, 2006
)
0.33
" For this photo case presentation, Dovobet was used once daily in combination with UVB phototherapy 3 times a week."( Calcipotriol (Dovobet) ointment in combination with UVB therapy for psoriasis treatment.
Rogers, C, 2006
)
0.33
"Treatment of plaque-type psoriasis with laser in combination with topical treatment is a safe and effective therapy."( Treatment of plaque-type psoriasis with the 308 nm excimer laser in combination with dithranol or calcipotriol.
Bodendorf, MO; Grunewald, S; Kauer, F; Paasch, U; Rogalski, C; Schetschorke, M; Simon, JC, 2012
)
0.38
"This study aimed to compare the efficacy of targeted microphototherapy alone and in combination with psoralen or calcipotriol in the treatment of plaque-type psoriasis."( Efficacy and safety of non-laser, targeted UVB phototherapy alone and in combination with psoralen gel or calcipotriol ointment in the treatment of localized, chronic, plaque-type psoriasis.
Arca, E; Köse, O; Ozkan, I; Ozmen, I, 2012
)
0.38
"Thirty individuals, affected by plaque-type psoriasis, were treated with targeted narrowband UVB phototherapy alone (Group 1), in combination with psoralen gel (Group 2), or in combination with calcipotriol ointment (Group 3) three times per week based on predetermined minimal erythema doses for 10 weeks."( Efficacy and safety of non-laser, targeted UVB phototherapy alone and in combination with psoralen gel or calcipotriol ointment in the treatment of localized, chronic, plaque-type psoriasis.
Arca, E; Köse, O; Ozkan, I; Ozmen, I, 2012
)
0.38
"005%) in combination with NB-UVB vs."( Comparison of efficacy and safety profile of topical calcipotriol ointment in combination with NB-UVB vs. NB-UVB alone in the treatment of vitiligo: a 24-week prospective right-left comparative clinical trial.
Kanwar, AJ; Khullar, G; Parsad, D; Singh, S, 2015
)
0.42
" Larger, randomized placebo-controlled trials are required to determine whether addition of calcipotriol has any utility when administered with NB-UVB in the treatment of vitiligo."( Comparison of efficacy and safety profile of topical calcipotriol ointment in combination with NB-UVB vs. NB-UVB alone in the treatment of vitiligo: a 24-week prospective right-left comparative clinical trial.
Kanwar, AJ; Khullar, G; Parsad, D; Singh, S, 2015
)
0.42
"The results of our study show that in the treatment of plaque-type psoriasis, topical calcipotriol combined with Spa Rusanda balineotherapy is more effective than topical calcipotriol alone."( Effects of Rusanda Spa balneotherapy combined with calcipotriol on plaque psoriasis.
Golusin, Z; Jovanović, M; Magda, N; Matić, M; Petrović, A; Stojanović, S, 2015
)
0.42
" Here, we investigated the efficacy of calcipotriol, a topical TSLP inducer, in combination with 5-fluorouracil (5-FU) as an immunotherapy for actinic keratosis."( Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy.
Cornelius, LA; Cunningham, TJ; Demehri, S; Eliane, JP; Kopan, R; Manivasagam, S; Mirzaalian, H; Saavedra, AP; Schaffer, A; Tabacchi, M; Tuchayi, SM; Turkoz, A; Wallendorf, M, 2017
)
0.46
"005% calcipotriol ointment combined with 5% 5-FU cream were compared with Vaseline plus 5-FU for the field treatment of actinic keratosis in a randomized, double-blind clinical trial involving 131 participants."( Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy.
Cornelius, LA; Cunningham, TJ; Demehri, S; Eliane, JP; Kopan, R; Manivasagam, S; Mirzaalian, H; Saavedra, AP; Schaffer, A; Tabacchi, M; Tuchayi, SM; Turkoz, A; Wallendorf, M, 2017
)
0.46
" The objective of this open label, intraindividual, left right study was to compare two different vitamin D analogues, calcipotriol and tacalcitol, in combination with NBUVB phototherapy in chronic stable plaque psoriasis."( Comparative evaluation of efficacy and safety of calcipotriol versus tacalcitol ointment, both in combination with NBUVB phototherapy in the treatment of stable plaque psoriasis.
Aggarwal, K; Dua, I; Jain, VK, 2017
)
0.46
" This pilot study assesses the effect of twice-weekly maintenance doses of Cal/BD foam after 4 weeks of standard once-daily treatment in combination with apremilast."( The Maintenance Effect of Calcipotriene 0.05% and Betamethasone Dipropionate 0.064% (Cal/BD) Aerosol Foam in Combination With Apremilast.
Kircik, L; Ozyurekoglu, E, 2022
)
0.72
" The objective of this open label intraindividual, left right study was to compare two different vitamin D analogues, calcipotriol and calcitriol, in combination with NBUVB phototherapy in psoriasis."( Comparative evaluation of efficacy and safety of calcipotriol versus calcitriol ointment, both in combination with narrow-band ultraviolet B phototherapy in the treatment of stable plaque psoriasis.
Aggarwal, K; Chakraborty, D, 2023
)
0.91

Bioavailability

ExcerptReferenceRelevance
" The differential therapeutic effects in the epidermal and dermal skin compartments may be due to a reduced bioavailability of calcipotriol in the dermal compartment."( Biologic effects of topical calcipotriol (MC 903) treatment in psoriatic skin.
Bahmer, FA; Baum, HP; Kerber, A; Müller, SM; Reichrath, J, 1997
)
0.3
" Such a formulation may provide convenience and enhanced activity compared with separate applications, but it is essential that the biological activity and bioavailability of either active agent is not adversely affected by the other component."( Bioavailability of betamethasone dipropionate when combined with calcipotriol.
Traulsen, J, 2004
)
0.32
"His study was designed to determine whether the bioavailability of the corticosteroid component of Daivobet was equivalent to that in a corticosteroid-only formulation (Diprosone, Schering-Plough Laboratories, France)."( Bioavailability of betamethasone dipropionate when combined with calcipotriol.
Traulsen, J, 2004
)
0.32
" When applied, Cal/BD foam forms a supersaturated solution on the skin, increasing the penetration and bioavailability of Cal and BD."( Early efficacy and safety data with fixed-dose combination calcipotriol/betamethasone dipropionate foam attributed to mechanism of absorption and steroid potency.
Iversen, L; Koo, J; Tada, Y, 2021
)
0.62

Dosage Studied

We report four cases of chronic plaque psoriasis that developed in patients who used UV-B phototherapy for a substantial period without ill effects. In whom photosensitivity reactions within psoriatic plaques developed after calcipotriene ointment was added. Three controlled clinical trials have demonstrated that the addition of calciptriene to systemic antipsoriatic treatment increases the therapeutic efficacy compared with systemic therapy alone.

ExcerptRelevanceReference
" Serum from MC903 or 1,25(OH)2D3 dosed rats (i."( Calcipotriol (MC 903): pharmacokinetics in rats and biological activities of metabolites. A comparative study with 1,25(OH)2D3.
Binderup, L; Kissmeyer, AM, 1991
)
0.28
"We report four cases of chronic plaque psoriasis that developed in patients who used UV-B phototherapy for a substantial period without ill effects and in whom photosensitivity reactions within psoriatic plaques developed after calcipotriene ointment was added, without changes in their UV-B dosage or frequency of treatment."( Photosensitivity associated with combined UV-B and calcipotriene therapy.
McKenna, KE; Stern, RS, 1995
)
0.29
"Twice-daily dosing of calcipotriene was compared with its vehicle, for up to 8 weeks, in a double-blind study of 277 patients at 10 study centers in the United States."( Calcipotriene ointment 0.005% for psoriasis: a safety and efficacy study. Calcipotriene Study Group.
Highton, A; Quell, J, 1995
)
0.29
" No changes in parameters of reproductive performance were seen in any dosed groups."( [Reproductive and developmental toxicity studies of calcipotriol (MC903): (1)--A fertility study in rats by subcutaneous administration].
Koike, Y; Konishi, R; Nagata, M; Ono, M; Shirakawa, K; Suzuki, T; Uchiyama, H, 1996
)
0.29
" A dose-response analysis showed that a 10(-6) M concentration of this vitamin consistently induced a maximal accumulation of 7-fold over the control cells."( Growth inhibition of human breast cancer cells by 1,25-dihydroxyvitamin D3 is accompanied by induction of apolipoprotein D expression.
Alvarez, S; Binderup, L; López-Boado, YS; López-Otín, C; Puente, XS; Tolivia, J, 1997
)
0.3
"These results underline the usefulness of the association of calcipotriol and cyclosporine in order to decrease the total dosage of cyclosporine."( Calcipotriol improves the efficacy of cyclosporine in the treatment of psoriasis vulgaris.
Kokelj, F; Plozzer, C; Torsello, P, 1998
)
0.3
" The objective of this study was to evaluate key measures of calcium metabolism in patients with psoriasis under supervised dosing conditions in a vehicle-controlled study."( Evaluating the safety of calcipotriene 30 g per day in patients with psoriasis: a parallel group, vehicle-controlled study.
Blum, R; Epinette, WW; Schwartzel, E; Siskin, S, 1998
)
0.3
" The mean number of sessions and the cumulative UVA dosage for initial and complete repigmentation were calculated."( Is the efficacy of psoralen plus ultraviolet A therapy for vitiligo enhanced by concurrent topical calcipotriol? A placebo-controlled double-blind study.
Alpsoy, E; Cetin, L; Ermis, O; Yilmaz, E, 2001
)
0.31
" Furthermore, in separate trials, calcipotriol combination therapy reduced the dosage of acitretin required to achieve clearance of psoriasis and the duration of PUVA and dosage of UVA phototherapy, potentially improving the benefit/risk ratio for these other antipsoriatic treatments."( Calcipotriol ointment. A review of its use in the management of psoriasis.
Dunn, CJ; Goa, KL; Scott, LJ, 2001
)
0.31
" In addition, calcipotriol ointment proved beneficial in combination with other topical, phototherapy or systemic antipsoriatic treatments, reducing the dosage and/or duration of some of these treatments and potentially improving their benefit/risk ratio."( Calcipotriol ointment. A review of its use in the management of psoriasis.
Dunn, CJ; Goa, KL; Scott, LJ, 2001
)
0.31
" Group A received FAE tablets (Fumaderm) with an increasing daily dosage from 105 to 1,075 mg + ointment vehicle."( Topical calcipotriol plus oral fumaric acid is more effective and faster acting than oral fumaric acid monotherapy in the treatment of severe chronic plaque psoriasis vulgaris.
Altmeyer, P; Christophers, E; Gollnick, H; Kaufmann, R; Pavel, S; Ring, J; Ziegler, J, 2002
)
0.31
"Little attention is given to accurate dosage of topical medication which is a potential source of side-effects and treatment failure."( The importance of accurate dosage of topical agents: a method of estimating involved area and application to calcipotriol treatment failures.
Hutchinson, PE; Osborne, JE, 2002
)
0.31
" Three controlled clinical trials have demonstrated that the addition of calcipotriene ointment to systemic antipsoriatic treatment with MTX, acitretin, and cyclosporine increases the therapeutic efficacy compared with systemic therapy alone and minimizes side effects by either reducing the dosage or duration of treatment."( Vitamin D and systemic therapy.
van de Kerkhof, P, 2002
)
0.31
" Group B included 33 patients treated with the same cyclosporin dosage plus, for the same time, topical application of calcipotriol cream twice a day."( Nail psoriasis: combined therapy with systemic cyclosporin and topical calcipotriol.
Amerio, P; Cerritelli, L; Feliciani, C; Forleo, P; Proietto, G; Tulli, A; Zampetti, A,
)
0.13
" This combination not only provides earlier pigmentation with lower total UVB dosage and less adverse UVB effects, but also reduces the duration and cost of treatment as well."( Combination of narrow band UVB and topical calcipotriol for the treatment of vitiligo.
Aydin, F; Canturk, MT; Goktas, EO; Senturk, N; Turanli, AY, 2006
)
0.33
" In addition to screening potential antipsoriatic substances, the PPT can help answer other questions (frequency of use, dose-response relationship)."( [Is the psoriasis plaque test still relevant in the age of biologicals?].
Wozel, G, 2006
)
0.33
" A dose-response trend existed for increasing concentrations of nicotinamide, but it was not significant."( Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis.
Andrashko, Y; Even-Chen, Z; Gottlieb, A; Lebwohl, M; Levine, D; Lipets, I; Pritulo, OA; Svyatenko, TV, 2010
)
0.36
"The relatively small patient numbers, relatively high placebo effect, and maximum in-life portion of only 12 weeks of dosing are weaknesses of the study."( Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis.
Andrashko, Y; Even-Chen, Z; Gottlieb, A; Lebwohl, M; Levine, D; Lipets, I; Pritulo, OA; Svyatenko, TV, 2010
)
0.36
"Etanercept is approved for the treatment of plaque psoriasis at a subcutaneous (SC) dosage of 50 mg twice-weekly for three months, followed by 50 mg SC once-weekly thereafter."( Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% maintains efficacy of etanercept after step-down dose in patients with moderate-to-severe plaque psoriasis: results of an open label trial.
Kircik, LH, 2011
)
0.37
" Liposomes can enhance the delivery of drugs into the skin, but a major challenge for the development of dosage forms containing liposomes is to maintain the colloidal stability in the formulation."( Calcipotriol delivery into the skin with PEGylated liposomes.
Basse, LH; Foged, C; Frokjaer, S; Hansen, J; Jorgensen, L; Knudsen, NØ; Rønholt, S; Salte, RD; Thormann, T, 2012
)
0.38
"Two chromatographic methods were developed, optimized and validated for simultaneous determination of calcipotriol monohydrate (CPM) and betamethasone dipropionate (BMD) in the presence of two dosage form additives named; butylated hydroxytoluene (BHT) and alpha-tocopherol (TOCO)."( Validated Chromatographic Methods for Simultaneous Determination of Calcipotriol Monohydrate and Betamethasone Dipropionate in the Presence of Two Dosage Form Additives.
El-Mosallamy, SS; El-Zeany, BA; Hassan, NY; Merey, HA, 2019
)
0.51
" Improvements in disease severity outcomes were maintained after reducing Cal/BD dosing frequency."( Adjunctive Use of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam in Patients With Psoriasis Treated With Ixekizumab.
Bagel, J; Nelson, E, 2022
)
0.72
" Twice-weekly maintenance application of topical Cal/BD aerosolized foam has recently been shown to prolong time to remission and is associated with fewer relapses in patients initially treated with standard dosing of the formulation."( The Maintenance Effect of Calcipotriene 0.05% and Betamethasone Dipropionate 0.064% (Cal/BD) Aerosol Foam in Combination With Apremilast.
Kircik, L; Ozyurekoglu, E, 2022
)
0.72
" A water-free lipid-based formulation system has been developed to improve dosage and cosmetic properties along with patient compliance."( Efficacy and Safety of Water-Free Lipid Formulation System Containing Calcipotriol Against Psoriasis Vulgaris.
Carlsson, A; Holmback, J; Rinwa, P, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antipsoriaticA drug used to treat psoriasis.
antipsoriaticA drug used to treat psoriasis.
drug allergenAny drug which causes the onset of an allergic reaction.
[role 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]

Drug Classes (6)

ClassDescription
hydrateAn addition compound that contains water in weak chemical combination with another compound.
hydroxy seco-steroid
seco-cholestane
cyclopropanesCyclopropane and its derivatives formed by substitution.
secondary alcoholA secondary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has two other carbon atoms attached to it.
triolA chemical compound containing three hydroxy groups.
[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)
USP1 protein, partialHomo sapiens (human)Potency63.09570.031637.5844354.8130AID504865
gemininHomo sapiens (human)Potency33.49830.004611.374133.4983AID624296
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency10.18150.005612.367736.1254AID624032
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Vitamin D3 receptorHomo sapiens (human)Kd0.00030.00012.46269.5200AID217167
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (28)

Processvia Protein(s)Taxonomy
negative regulation of DNA-templated transcriptionVitamin D3 receptorHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIVitamin D3 receptorHomo sapiens (human)
cell morphogenesisVitamin D3 receptorHomo sapiens (human)
skeletal system developmentVitamin D3 receptorHomo sapiens (human)
calcium ion transportVitamin D3 receptorHomo sapiens (human)
intracellular calcium ion homeostasisVitamin D3 receptorHomo sapiens (human)
lactationVitamin D3 receptorHomo sapiens (human)
negative regulation of cell population proliferationVitamin D3 receptorHomo sapiens (human)
positive regulation of gene expressionVitamin D3 receptorHomo sapiens (human)
negative regulation of keratinocyte proliferationVitamin D3 receptorHomo sapiens (human)
positive regulation of vitamin D 24-hydroxylase activityVitamin D3 receptorHomo sapiens (human)
positive regulation of bone mineralizationVitamin D3 receptorHomo sapiens (human)
phosphate ion transmembrane transportVitamin D3 receptorHomo sapiens (human)
bile acid signaling pathwayVitamin D3 receptorHomo sapiens (human)
mRNA transcription by RNA polymerase IIVitamin D3 receptorHomo sapiens (human)
positive regulation of keratinocyte differentiationVitamin D3 receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIVitamin D3 receptorHomo sapiens (human)
decidualizationVitamin D3 receptorHomo sapiens (human)
intestinal absorptionVitamin D3 receptorHomo sapiens (human)
apoptotic process involved in mammary gland involutionVitamin D3 receptorHomo sapiens (human)
positive regulation of apoptotic process involved in mammary gland involutionVitamin D3 receptorHomo sapiens (human)
regulation of calcidiol 1-monooxygenase activityVitamin D3 receptorHomo sapiens (human)
mammary gland branching involved in pregnancyVitamin D3 receptorHomo sapiens (human)
vitamin D receptor signaling pathwayVitamin D3 receptorHomo sapiens (human)
positive regulation of vitamin D receptor signaling pathwayVitamin D3 receptorHomo sapiens (human)
response to bile acidVitamin D3 receptorHomo sapiens (human)
multicellular organism developmentVitamin D3 receptorHomo sapiens (human)
cell differentiationVitamin D3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (12)

Processvia Protein(s)Taxonomy
DNA-binding transcription factor activityVitamin D3 receptorHomo sapiens (human)
vitamin D response element bindingVitamin D3 receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificVitamin D3 receptorHomo sapiens (human)
DNA bindingVitamin D3 receptorHomo sapiens (human)
nuclear receptor activityVitamin D3 receptorHomo sapiens (human)
protein bindingVitamin D3 receptorHomo sapiens (human)
zinc ion bindingVitamin D3 receptorHomo sapiens (human)
bile acid nuclear receptor activityVitamin D3 receptorHomo sapiens (human)
nuclear retinoid X receptor bindingVitamin D3 receptorHomo sapiens (human)
calcitriol bindingVitamin D3 receptorHomo sapiens (human)
lithocholic acid bindingVitamin D3 receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingVitamin D3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (6)

Processvia Protein(s)Taxonomy
nucleusVitamin D3 receptorHomo sapiens (human)
nucleusVitamin D3 receptorHomo sapiens (human)
nucleoplasmVitamin D3 receptorHomo sapiens (human)
cytosolVitamin D3 receptorHomo sapiens (human)
RNA polymerase II transcription regulator complexVitamin D3 receptorHomo sapiens (human)
chromatinVitamin D3 receptorHomo sapiens (human)
receptor complexVitamin D3 receptorHomo sapiens (human)
[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.
AID1613156Induction of apoptosis in human MCF7 cells assessed as early apoptotic cells at 1 uM after 48 hrs by Annexin V-FITC/propidium iodide staining-based flow cytometric analysis (Rvb = 3.80%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
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).
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).
AID1613157Induction of apoptosis in human MCF7 cells assessed as late apoptotic cells at 1 uM after 48 hrs by Annexin V-FITC/propidium iodide staining-based flow cytometric analysis (Rvb = 1.61%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1613162Cell cycle arrest in human MCF7 cells assessed as accumulation at G2/M phase at 1 uM after 24 hrs by propidium iodide staining based flow cytometric analysis (Rvb = 12.04%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
AID1423172Hepatoprotective activity against CCL4-induced liver damage in C57BL/6J mouse assessed as reduction in serum ALT levels at 20 ug/kg, po administered 5 times a week via gavage measured at 72 hrs post final CCl4 injection2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
AID1613159Induction of apoptosis in human MCF7 cells assessed as viable cells at 1 uM after 48 hrs by Annexin V-FITC/propidium iodide staining-based flow cytometric analysis (Rvb = 94.3%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
AID1353234Transactivation of VDR (unknown origin) expressed in HEK293 cells harboring pENTER-CMV-human RXRalpha at 10'-8M to 10'-6M after 24 hrs by luciferase reporter gene assay2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
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).
AID1353235Antifibrotic activity against TGFbeta1 stimulated rat LTC-14 cells assessed as inhibition of collagen 1 synthesis at 0.5 uM after 24 hrs by ELISA relative to calcipotriol2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
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).
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
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).
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID217167Binding affinity to VDR receptor2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
New dermatological agents for the treatment of psoriasis.
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).
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).
AID1353231Toxicity in caerulein induced chronic pancreatic C57BL/6J mouse model assessed as serum calcium levels at 0.5 mg/kg, po administered via gavage treated for 5 times per week measured after 3 days (Rvb = 0.25 umol/ml)2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID1423169Antifibrotic activity in C57BL/6J mouse model of CCl4-induced liver fibrosis assessed as reduction in hydroxyproline levels in liver at 20 ug/kg, po administered 5 times a week via gavage measured at 72 hrs post final CCl4 injection2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID216993Binding of compound towards human Vitamin D3 receptor was determined in vitro2004Journal of medicinal chemistry, Apr-08, Volume: 47, Issue:8
Crystal structures of the vitamin D nuclear receptor liganded with the vitamin D side chain analogues calcipotriol and seocalcitol, receptor agonists of clinical importance. Insights into a structural basis for the switching of calcipotriol to a receptor
AID1353252Toxicity in caerulein induced chronic pancreatic C57BL/6J mouse model assessed as reduction in body weight at 0.5 mg/kg, po administered via gavage treated for 5 times per week measured after 3 days2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID89329Inhibition of growth of human keratinocytes2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
New dermatological agents for the treatment of psoriasis.
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).
AID1423157Binding affinity to VDR ligand binding domain (unknown origin) at 100 nM by fluorescence polarization assay relative to calcipotriol2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
AID1353239Antifibrotic activity against TGFbeta1 stimulated rat LTC-14 cells assessed as inhibition of alpha-SMA mRNA expression at 500 nM after 24 hrs by RT-qPCR analysis2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID1353236Antifibrotic activity against TGFbeta1 stimulated rat LTC-14 cells assessed as inhibition of collagen 1 level at 500 nM after 24 hrs by Western blot2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID1613163Cell cycle arrest in human MCF7 cells assessed as accumulation at S phase at 1 uM after 24 hrs by propidium iodide staining based flow cytometric analysis (Rvb = 31.32%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
AID1423173Hepatoprotective activity against CCL4-induced liver damage in C57BL/6J mouse assessed as reduction in serum TBA levels at 20 ug/kg, po administered 5 times a week via gavage measured at 72 hrs post final CCl4 injection2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
AID1353232Inhibition of fluoromone VDR red binding to human VDR LBD expressed in insect cells at 1 uM by fluorescent polarization assay relative to 1,25(OH)2D32018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID1353238Antifibrotic activity against TGFbeta1 stimulated rat LTC-14 cells assessed as inhibition of collagen 1 alpha 1 mRNA expression at 500 nM after 24 hrs by RT-qPCR analysis2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID1423158Agonist activity at VDR in human LX2 cells assessed as inhibition of TGFbeta1-induced collagen-1 synthesis at 100 nM after 24 hrs by ELISA relative to calcipotriol2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
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).
AID1613158Induction of apoptosis in human MCF7 cells assessed as necrotic cells at 1 uM after 48 hrs by Annexin V-FITC/propidium iodide staining-based flow cytometric analysis (Rvb = 0.29%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
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).
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).
AID1353237Antifibrotic activity against TGFbeta1 stimulated rat LTC-14 cells assessed as inhibition of alpha-SMA level at 500 nM after 24 hrs by Western blot2018European journal of medicinal chemistry, Feb-25, Volume: 146Design, synthesis and biological evaluation of non-secosteriodal vitamin D receptor ligand bearing double side chain for the treatment of chronic pancreatitis.
AID1423171Hepatoprotective activity against CCL4-induced liver damage in C57BL/6J mouse assessed as reduction in serum AST levels at 20 ug/kg, po administered 5 times a week via gavage measured at 72 hrs post final CCl4 injection2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
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).
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).
AID216996Effective concentration required for inhibition of Vitamin D3 receptor; No data2004Journal of medicinal chemistry, Apr-08, Volume: 47, Issue:8
Crystal structures of the vitamin D nuclear receptor liganded with the vitamin D side chain analogues calcipotriol and seocalcitol, receptor agonists of clinical importance. Insights into a structural basis for the switching of calcipotriol to a receptor
AID1613161Cell cycle arrest in human MCF7 cells assessed as accumulation at G0/G1 phase at 1 uM after 24 hrs by propidium iodide staining based flow cytometric analysis (Rvb = 56.64%)2019European journal of medicinal chemistry, Feb-01, Volume: 163Discovery of novel nonsteroidal VDR agonists with novel diarylmethane skeleton for the treatment of breast cancer.
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).
AID1902983Toxicity in IMQ-induced BALB/c psoriasis mouse model assessed as body weight lossas at 0.05% ointment, TOP daily and measured after 4 days2022Journal of medicinal chemistry, 03-10, Volume: 65, Issue:5
Discovery and Structural Optimization of Toddacoumalone Derivatives as Novel PDE4 Inhibitors for the Topical Treatment of Psoriasis.
AID1423163Transactivation of VDR in human LX2 cells assessed as inhibition of TGFbeta1-induced COL1A1 mRNA expression at 100 nM after 24 hrs by Q-PCR analysis2018Journal of medicinal chemistry, 12-13, Volume: 61, Issue:23
Design, Synthesis, and Antifibrosis Activity in Liver of Nonsecosteroidal Vitamin D Receptor Agonists with Phenyl-pyrrolyl Pentane Skeleton.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID977611Experimentally measured binding affinity data (Kd) for protein-ligand complexes derived from PDB2001Journal of medicinal chemistry, Feb-01, Volume: 44, Issue:3
New dermatological agents for the treatment of psoriasis.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,063)

TimeframeStudies, This Drug (%)All Drugs %
pre-19907 (0.66)18.7374
1990's305 (28.69)18.2507
2000's313 (29.44)29.6817
2010's289 (27.19)24.3611
2020's149 (14.02)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials338 (30.29%)5.53%
Trials0 (0.00%)5.53%
Reviews160 (14.34%)6.00%
Reviews1 (10.00%)6.00%
Case Studies167 (14.96%)4.05%
Case Studies0 (0.00%)4.05%
Observational8 (0.72%)0.25%
Observational0 (0.00%)0.25%
Other443 (39.70%)84.16%
Other9 (90.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (121)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT02533973]Phase 4951 participants (Actual)Interventional2015-09-30Completed
[NCT01105286]Phase 124 participants (Actual)Interventional2010-04-30Completed
A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris. [NCT01297166]Phase 125 participants (Actual)Interventional2011-02-28Completed
A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis V [NCT02416258]Phase 250 participants (Actual)Interventional2015-04-30Completed
An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis [NCT04227288]Phase 43 participants (Actual)Interventional2021-11-01Completed
Study Role of the Local Treatments on the Microbiome Modulation in the Psoriatic Skin. Study Monocentric, Interventional, Randomized and Single-blind [NCT03584360]Phase 230 participants (Actual)Interventional2018-09-24Completed
Phase II Study of a Non-Steroidal Novel Treatment for Scalp Psoriasis [NCT01368887]Phase 2160 participants (Anticipated)Interventional2013-04-30Suspended(stopped due to Sponsor seeking additional financial support before starting the study)
A Phase II Multicenter Randomized Double-blind Comparator-Controlled Trial of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis [NCT03848806]Phase 2174 participants (Actual)Interventional2016-02-29Completed
A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis [NCT01582932]Phase 136 participants (Actual)Interventional2013-04-30Completed
Calcipotriol Plus 5-Fluorouracil Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients [NCT04642287]Phase 264 participants (Anticipated)Interventional2026-01-31Not yet recruiting
Calcipotriol Plus 5-Flourouracil Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients [NCT04329221]Phase 262 participants (Anticipated)Interventional2026-01-01Not yet recruiting
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH M [NCT03469336]Phase 118 participants (Actual)Interventional2018-04-24Completed
[NCT01301157]Phase 2294 participants (Actual)Interventional2011-02-28Completed
Phase I, Single-center, Randomized, Controlled Trial to Evaluate the Antipsoriatic Efficacy of Calcipotriol in Novel Formulations Compared to Marketed Calcipotriol Products and Evaluation of Their Cutaneous Safety in a Psoriasis Plaque Test [NCT05488990]Phase 1/Phase 224 participants (Actual)Interventional2013-03-25Completed
Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma Versus Combined of Both on Serum Adiponectin Level in Alopecia Areata [NCT05954104]80 participants (Actual)Interventional2023-07-01Completed
A Phase II Study of the Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis [NCT00625326]Phase 2321 participants (Actual)Interventional2008-01-31Completed
An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects [NCT01105234]Phase 124 participants (Actual)Interventional2010-04-30Completed
Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis [NCT03880357]Phase 1485 participants (Actual)Interventional2018-10-22Completed
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial [NCT03847441]60 participants (Actual)Interventional2017-10-01Completed
Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis [NCT03441789]Phase 428 participants (Actual)Interventional2017-09-18Completed
A 28-day, Double-blind, Randomized, Reference-controlled Open Psoriasis Plaque Test for Within Subject Comparison of Efficacy and Safety of Mapracorat 0.1% Ointment and 4 Reference Products in Symptomatic Volunteers With Stable Plaque-type Psoriasis [NCT03399526]Phase 124 participants (Actual)Interventional2013-02-11Completed
A Phase 1b, Randomised, Controlled, Assessor-blinded Proof of Principle Trial to Assess Safety, Tolerability and Pharmacodynamics Effects of Microarray Patches Containing Calcipotriol/Betamethasone Dipropionate in Descaled Skin of Adults With Chronic Plaq [NCT03898583]Phase 115 participants (Actual)Interventional2019-04-15Completed
Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis [NCT02856542]1,560 participants (Actual)Observational2016-05-23Completed
A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Syst [NCT00574249]Phase 3730 participants (Actual)Interventional2007-11-30Completed
An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects [NCT03448081]Phase 273 participants (Actual)Interventional2018-02-12Completed
Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris [NCT02191007]230 participants (Actual)Interventional2013-11-30Completed
Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ [NCT05381597]Phase 2/Phase 3200 participants (Anticipated)Interventional2022-10-15Recruiting
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Patients With Moderate to Severe Psoriasis [NCT04275024]8 participants (Actual)Interventional2020-04-01Completed
Efficacy and Safety of Expanded Allogeneic Adipose-derived Mesenchymal Stem Cells Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis [NCT03392311]Phase 1/Phase 28 participants (Actual)Interventional2019-07-23Completed
A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) With Plaque Psoriasis [NCT01563068]Phase 118 participants (Actual)Interventional2012-04-30Completed
A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis. [NCT00987870]Phase 1/Phase 215 participants (Actual)Interventional2009-09-30Completed
A Psoriasis Plaque Study Comparing Clobetasol Propionate Plus Calcipotriol Ointment With Clobetasol Propionate Ointment Alone, Calcipotriol Ointment Alone and a Vehicle Control for the Treatment of Psoriasis Vulgaris [NCT01043224]Phase 124 participants (Actual)Interventional2010-01-31Completed
A Single-Center, Randomized, Blinded, Vehicle- Controlled Exploratory Study to Assess the Activity of CRx-197 in Subjects With Plaque Psoriasis [NCT00796211]Phase 220 participants (Anticipated)Interventional2008-11-30Completed
A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque [NCT04221906]Phase 115 participants (Actual)Interventional2020-01-06Completed
A Phase III, Multicentre, Randomized, Observer Blind, Parallel Group, Three Arms, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Topically Applied Calcipotriol/AKVANO 50 μg/g Cutaneous Solution Against Calcipotriol Ointment 50 Micrograms [NCT05174598]Phase 3278 participants (Actual)Interventional2018-10-03Completed
Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial [NCT04071106]Phase 2/Phase 350 participants (Anticipated)Interventional2019-09-01Not yet recruiting
Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp [NCT03996252]Early Phase 115 participants (Actual)Interventional2019-07-01Terminated(stopped due to The study team was not able to start the study and they never completed the IRB submission, so the study was terminated.)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to [NCT03731091]Phase 3494 participants (Actual)Interventional2018-10-31Completed
LEO 19123 Cream in the Treatment of Psoriasis Vulgaris [NCT00764751]Phase 251 participants (Actual)Interventional2008-09-30Completed
A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis [NCT00820950]Phase 229 participants (Actual)Interventional2007-05-31Completed
A Randomized, Single-Blind, Active Control, 18-Week Study to Evaluate the Safety and Efficacy of A New Twice-Daily, Topically Applied LCD Solution vs. Calcipotriol Cream for the Treatment of Adult Subjects With Moderate Plaque Psoriasis [NCT00705900]60 participants (Anticipated)Interventional2007-01-31Completed
Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea [NCT02680717]Phase 10 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to Unable to obtain IRB approval at all sites)
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2 [NCT00656019]Phase 263 participants (Actual)Interventional2008-04-30Completed
Xamiol® Gel in BODY Psoriasis : lonG-term Management of Psoriasis vUlgARis With Xamiol® Gel in Daily Clinical Practice of Russian Dermatologists. A Long-term Observational, Prospective Study [NCT02636101]603 participants (Actual)Observational2016-01-31Completed
[NCT02733874]Phase 4240 participants (Actual)Interventional2015-04-30Completed
Assessing the Efficacy and Safety of Metformin in Treatment of Moderate Psoriasis: A Prospective Randomized Double Blind Controlled Study [NCT02644954]Phase 340 participants (Anticipated)Interventional2016-01-31Not yet recruiting
Calcipotriol in the Prevention of Polymorphic Light Eruption [NCT00871052]13 participants (Actual)Interventional2009-03-31Completed
LEO19123 Cream in the Treatment of Hand Eczema [NCT00404196]Phase 275 participants (Anticipated)Interventional2006-10-31Completed
One-year Prospective, Observational Study of the Journey of Patients With Plaque Psoriasis Prescribed Calcipotriol/Betamethasone Aerosol Foam or Other Topical Therapy [NCT02935582]1,214 participants (Actual)Observational2017-01-31Completed
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis [NCT00216827]Phase 31,485 participants Interventional2004-11-30Completed
Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris [NCT02004574]Phase 4201 participants (Actual)Interventional2013-10-31Completed
Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris [NCT01422434]Phase 3676 participants (Actual)Interventional2011-07-31Completed
The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions [NCT02019355]Early Phase 1132 participants (Actual)Interventional2013-10-31Completed
A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis [NCT02940002]Phase 123 participants (Actual)Interventional2016-10-12Completed
A Phase I, Single-Center, Randomized, Vehicle-Controlled Study, Double-Blind for the Study Preparations and Observer-Blind for the Comparators to Determine the Antipsoriatic Efficacy and Tolerability of Topical Formulations With Ciclosporin in a Psoriasis [NCT00578370]Phase 1/Phase 225 participants (Anticipated)Interventional2007-11-30Completed
Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis After Combination Treatment of Lexette and Sorilux for 2 Weeks [NCT04571151]Phase 430 participants (Anticipated)Interventional2021-01-31Not yet recruiting
The Maintenance Effect of Enstilar Foam in Combination With Otezla [NCT04555707]Phase 430 participants (Anticipated)Interventional2020-06-24Recruiting
Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis. [NCT01195831]Phase 3244 participants (Actual)Interventional2010-09-30Completed
A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band U [NCT03020199]Phase 4196 participants (Actual)Interventional2017-03-27Completed
A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay. [NCT01646567]Phase 114 participants (Actual)Interventional2012-09-30Completed
A Multicenter, Randomized, Double-Blind Study of the Safety and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam In The Treatment Of Moderate Plaque-Type Scalp And Body Psoriasis [NCT01139580]Phase 3363 participants (Actual)Interventional2010-05-31Completed
Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions [NCT02881346]410 participants (Actual)Observational2016-09-30Completed
Nickel Desensitization Using Topical Therapy [NCT01413477]24 participants (Anticipated)Interventional2011-08-31Not yet recruiting
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis [NCT00216840]Phase 31,350 participants Interventional2004-12-31Completed
Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel [NCT00216879]Phase 3800 participants Interventional2005-02-28Completed
An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents [NCT03080545]Phase 425 participants (Actual)Interventional2017-05-01Completed
Efficacy and Safety of HAT1, a Novel Topical Therapeutic: An Open Label Pilot Study of HAT1 Compared to Calcipotriol in Patients With Chronic Plaque Psoriasis [NCT03069144]Phase 1/Phase 228 participants (Actual)Interventional2012-01-06Completed
Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast. [NCT00445250]Phase 250 participants InterventionalNot yet recruiting
A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris [NCT00875277]Phase 224 participants (Actual)Interventional2009-04-30Completed
Observational and Prospective Study in Patients With Nail Psoriasis Treated With Calcipotriene and Betamethasone Dipropionate Aerosol Foam to Evaluate the Change in the Severity of Psoriasis and in the Quality of Life [NCT04380597]10 participants (Actual)Observational2019-03-26Completed
Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas [NCT00691002]Phase 31,245 participants (Actual)Interventional2008-05-31Completed
Effect of Calcipotriol Plus Hydrocortisone Ointment on the Hypothalamic-pituitary-adrenal (HPA) Axis and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and on the Intertriginous Areas [NCT00704262]Phase 233 participants (Actual)Interventional2008-05-31Completed
An Open Label Study to Evaluate the Clinical Response to Sequential Treatment With Daivobet and Daivonex in Patients With Mild to Moderate Psoriasis [NCT00437619]Phase 4200 participants (Actual)Interventional2007-02-28Completed
LEO19123 Cream in the Treatment of Atopic Dermatitis [NCT00392067]Phase 275 participants (Anticipated)Interventional2006-10-31Completed
A Phase I Exploratory Study Evaluating 3 Formulations of LEO 29102 Plus Calcipotriol, Ointment, LEO 29102 Ointment, Calcipotriol Ointment, Daivonex® Ointment and Diprosone® Ointment in the Treatment of Psoriasis [NCT01466478]Phase 124 participants (Actual)Interventional2011-11-30Completed
Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris [NCT00216892]Phase 41,032 participants Interventional2005-04-30Completed
A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris [NCT00670241]Phase 3458 participants (Actual)Interventional2008-04-30Completed
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris [NCT00817219]Phase 233 participants (Actual)Interventional2009-07-31Completed
A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia [NCT05416320]Early Phase 10 participants (Actual)Interventional2023-08-31Withdrawn(stopped due to The IRB was closed without enrolling any participants)
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris [NCT00263718]Phase 2360 participants Interventional2005-12-31Completed
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis [NCT00243464]Phase 3300 participants Interventional2005-09-30Completed
A Randomised, Double-Blind, Active-Controlled, Parallel, Multi-Center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris [NCT00248456]Phase 4320 participants Interventional2005-10-31Completed
Calcipotriene Plus Betamethasone Dipropionate Gel Compared to the Gel Vehicle in Scalp Psoriasis, in Patients Receiving Calcipotriene Plus Betamethasone Dipropionate Ointment for Psoriasis Vulgaris of Trunk/Limbs [NCT00279162]Phase 3160 participants (Anticipated)Interventional2005-12-31Completed
An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab [NCT03827876]Phase 430 participants (Anticipated)Interventional2019-01-16Recruiting
Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test [NCT01743118]Phase 124 participants (Actual)Interventional2013-03-31Completed
Evaluation of Topical Nicotinamide in Combination With Calcipotriol Compared With Calcipotriol Alone for the Treatment of Mild to Moderate Psoriasis. [NCT01763424]Phase 2/Phase 366 participants (Actual)Interventional2011-07-31Completed
A Phase 2 Study Comparing Treatment With LEO 90100 With Calcipotriol Plus Betamethasone Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris. [NCT01536886]Phase 2376 participants (Actual)Interventional2012-05-31Completed
[NCT01536938]Phase 2303 participants (Actual)Interventional2012-05-31Completed
The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients [NCT03848871]Phase 420 participants (Actual)Interventional2017-12-12Completed
Molecular Effects of Topical Calcipotriene on Morphea [NCT02411643]Early Phase 12 participants (Actual)Interventional2015-03-31Terminated(stopped due to Accrual incomplete/Investigator left institution)
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract and Calcipotriol Solution in Patients With Nail Psoriasis [NCT01445886]Phase 2/Phase 333 participants (Actual)Interventional2011-01-31Completed
A Phase 1 Randomized, Placebo and Active Comparator-controlled Trial, Double-blind for the IPs, Observer-blind for the Active Comparator, to Assess the Potency of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment in a Psoriasis Plaque Test [NCT03004339]Phase 113 participants (Actual)Interventional2016-08-31Completed
Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris [NCT01707043]Phase 420 participants (Actual)Interventional2012-10-31Completed
A Randomized Phase III, Three-parallel Arm, Assessor Blind, Multi-centre Study to Evaluate the Efficacy, Safety and Tolerability of AKP02 Cutaneous Spray Versus Enstilar Cutaneous Foam in Subjects With Mild to Moderate Psoriasis. [NCT05249972]Phase 3294 participants (Anticipated)Interventional2022-01-24Recruiting
A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris [NCT01268527]Phase 230 participants (Actual)Interventional2010-03-15Completed
Phase IIA, Single-Arm, Open- Label, Clinical Trial of Calcipotriene Plus 5-Fluorouracil Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients [NCT05699603]Phase 256 participants (Anticipated)Interventional2023-11-01Not yet recruiting
The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo [NCT03234673]Phase 130 participants (Anticipated)Interventional2017-08-31Not yet recruiting
An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis [NCT00437255]Phase 4122 participants (Actual)Interventional2006-08-31Completed
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis [NCT01745133]Phase 463 participants (Actual)Interventional2013-01-31Completed
A Phase 1, Single- Center, Randomized, Double-blind, Vehicle And Active Comparator-controlled Trial To Evaluate The Antipsoriatic Activity And Safety Of A Topically Applied Pf-06263276 Formulation In A Psoriasis Plaque Test [NCT02193815]Phase 115 participants (Actual)Interventional2014-09-30Completed
A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topica [NCT01188928]Phase 31,152 participants (Actual)Interventional2010-09-30Completed
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva). [NCT00608777]Phase 46 participants (Actual)Interventional2008-01-31Terminated(stopped due to Withdrawal of marketing autorization of efalizumab by the EMEA.)
Efficacy of Topical Calcipotriol-assisted Ablative Fractional Laser Photodynamic Therapy for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial [NCT02976727]Phase 148 participants (Actual)Interventional2014-05-31Completed
Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study [NCT02878382]20 participants (Actual)Interventional2016-10-31Completed
Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial [NCT02858713]Phase 4134 participants (Actual)Interventional2017-01-09Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Lt [NCT03331523]Phase 3643 participants (Actual)Interventional2017-10-20Completed
A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test [NCT02432027]Phase 1/Phase 214 participants (Actual)Interventional2015-06-30Completed
A Randomized, Doubleblind, Vehicle-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis [NCT03079973]Phase 30 participants (Actual)Interventional2017-05-15Withdrawn(stopped due to Project development priorities changed.)
Innate Immunity in Acne Vulgaris [NCT01694433]Phase 2/Phase 366 participants (Actual)Interventional2013-02-28Completed
A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intert [NCT00640822]Phase 3782 participants (Actual)Interventional2008-02-29Completed
[NCT01837576]Phase 124 participants (Actual)Interventional2013-04-30Completed
Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo [NCT04440371]40 participants (Anticipated)Interventional2020-06-21Active, not recruiting
Clinical Effectiveness of Calcipotriene in Acute Graft Versus Host Disease of the Skin: A Pilot Study [NCT03093805]10 participants (Actual)Interventional2017-03-15Completed
LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris [NCT02132936]Phase 3504 participants (Actual)Interventional2014-06-30Completed
Combination Topical 5-fluorouracil 5% / Calcipotriene 0.005% Cream for Treatment of in Situ and Superficially Invasive Squamous Cell Carcinoma of the Skin [NCT04839731]Early Phase 130 participants (Anticipated)Interventional2021-04-14Recruiting
A Pilot Trial of Topical Calcipotriene Treatment for Breast Cancer Immunoprevention [NCT03596073]Phase 1120 participants (Anticipated)Interventional2018-11-07Recruiting
A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis [NCT03122353]Phase 1699 participants (Actual)Interventional2017-04-11Completed
Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study [NCT06011083]40 participants (Actual)Interventional2022-08-01Completed
Open Clinical Study, Comparing Non-inferiority for Efficacy of the Drug Tazarotene 0.1% Versus the Comparator Drug Calcipotriol 0.005% in the Treatment of Chronic Plaque Psoriasis [NCT01279629]50 participants (Anticipated)Observational2011-02-28Suspended
A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034 [NCT00358384]Phase 110 participants (Actual)Interventional2005-09-26Completed
A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris [NCT01580488]Phase 124 participants (Actual)Interventional2012-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00574249 (18) [back to overview]Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.
NCT00574249 (18) [back to overview]Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.
NCT00574249 (18) [back to overview]Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
NCT00574249 (18) [back to overview]Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
NCT00574249 (18) [back to overview]Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
NCT00574249 (18) [back to overview]Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
NCT00640822 (1) [back to overview]Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
NCT00656019 (1) [back to overview]Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer
NCT00670241 (5) [back to overview]Subjects With Relapse During the Study
NCT00670241 (5) [back to overview]Subjects With Rebound During the Study
NCT00670241 (5) [back to overview]"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"
NCT00670241 (5) [back to overview]The Percentage Change in PASI From Baseline to Week 8
NCT00670241 (5) [back to overview]"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"
NCT00691002 (5) [back to overview]"Participants With Success According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase"
NCT00691002 (5) [back to overview]"Participants With Success According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase"
NCT00691002 (5) [back to overview]"Participants With Controlled Disease According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase"
NCT00691002 (5) [back to overview]"Participants With Controlled Disease According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase"
NCT00691002 (5) [back to overview]"Participants With Controlled Disease According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase"
NCT00704262 (13) [back to overview]Serum Cortisol Concentration After 30 Minutes
NCT00704262 (13) [back to overview]Overall Disease Severity of the Face According to the IGA
NCT00704262 (13) [back to overview]Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range
NCT00704262 (13) [back to overview]"Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face"
NCT00704262 (13) [back to overview]"Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas"
NCT00704262 (13) [back to overview]The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes
NCT00704262 (13) [back to overview]The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes
NCT00704262 (13) [back to overview]The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes
NCT00704262 (13) [back to overview]Overall Disease Severity of Intertriginous Areas According to the IGA
NCT00704262 (13) [back to overview]Serum Cortisol Concentration After 60 Minutes
NCT00704262 (13) [back to overview]Albumin Corrected Serum Calcium
NCT00704262 (13) [back to overview]Change in Albumin Corrected Serum Calcium
NCT00704262 (13) [back to overview]Change in Albumin Corrected Serum Calcium
NCT00764751 (4) [back to overview]The Absolute Change in PASI (Psoriasis Area Severity Index)
NCT00764751 (4) [back to overview]The Percentage Change in PASI (Psoriasis Area Severity Index)
NCT00764751 (4) [back to overview]Participant's Overall Assessment of Treatment Response
NCT00764751 (4) [back to overview]Participant's Assessment of Treatment Preference
NCT00817219 (10) [back to overview]Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
NCT00817219 (10) [back to overview]Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
NCT00817219 (10) [back to overview]Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
NCT00817219 (10) [back to overview]PASI 75 at Week 4.
NCT00817219 (10) [back to overview]PASI 50 at Week 4.
NCT00817219 (10) [back to overview]Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
NCT00817219 (10) [back to overview]Adverse Drug Reactions
NCT00817219 (10) [back to overview]"Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4."
NCT00817219 (10) [back to overview]"Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4."
NCT00817219 (10) [back to overview]Percentage Change in PASI From Baseline to Week 4.
NCT00820950 (6) [back to overview]Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
NCT00820950 (6) [back to overview]Change in Target Lesion Area Compared to Baseline
NCT00820950 (6) [back to overview]Number of Participants With Treatment Emergent Adverse Events
NCT00820950 (6) [back to overview]Pharmacokinetics Parameter : Bioavailability of INCB018424
NCT00820950 (6) [back to overview]Pharmacokinetics Parameter : Skin Flux of INCB018424
NCT00820950 (6) [back to overview]Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
NCT00875277 (13) [back to overview]Change in Infiltration Compared to Baseline
NCT00875277 (13) [back to overview]Biomarkers by Immunochemistry
NCT00875277 (13) [back to overview]Pathology and Histology by Treatment: Epidermal Thickness
NCT00875277 (13) [back to overview]Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
NCT00875277 (13) [back to overview]Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
NCT00875277 (13) [back to overview]Biomarkers by Immunochemistry: Epidermal Proliferation
NCT00875277 (13) [back to overview]Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
NCT00875277 (13) [back to overview]Pathology and Histology by Treatment
NCT00875277 (13) [back to overview]Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
NCT00875277 (13) [back to overview]Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
NCT00875277 (13) [back to overview]Change in Scaling Compared to Baseline
NCT00875277 (13) [back to overview]Change in Erythema Compared to Baseline
NCT00875277 (13) [back to overview]Biomarkers by Immunochemistry: Epidermal Differentiation
NCT01139580 (6) [back to overview]Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8
NCT01139580 (6) [back to overview]Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8
NCT01139580 (6) [back to overview]Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)
NCT01139580 (6) [back to overview]Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method
NCT01139580 (6) [back to overview]Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8
NCT01139580 (6) [back to overview]Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
NCT01188928 (4) [back to overview]Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4
NCT01188928 (4) [back to overview]Mean Percentage Change in PASI From Baseline to Week 8
NCT01188928 (4) [back to overview]Mean Percentage Change in PASI From Baseline to Week 4
NCT01188928 (4) [back to overview]Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8
NCT01195831 (5) [back to overview]Patients With Success (Total Sign Score ≤1) at Week 4
NCT01195831 (5) [back to overview]"Patients With Controlled Disease in Terms of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 2."
NCT01195831 (5) [back to overview]"Patients With Controlled Disease in Terms of Clear or Minimal According to Investigator's Global Assessment of Disease Severity at Week 4."
NCT01195831 (5) [back to overview]"Patients With Controlled Disease in Terms of Clear or Minimal According to Investigator's Global Assessment of Disease Severity at Week 2"
NCT01195831 (5) [back to overview]"Patients With Controlled Disease in Term of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 4."
NCT01268527 (6) [back to overview]Overview of Treatment-Emergent Adverse Events (TEAEs)
NCT01268527 (6) [back to overview]Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation
NCT01268527 (6) [back to overview]Clinical (Global) Assessment of Efficacy on Day 8
NCT01268527 (6) [back to overview]Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate
NCT01268527 (6) [back to overview]Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation)
NCT01268527 (6) [back to overview]Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8
NCT01422434 (4) [back to overview]Change in mPASI From Baseline to Week 1
NCT01422434 (4) [back to overview]Physician's Global Assessment of Psoriasis
NCT01422434 (4) [back to overview]Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
NCT01422434 (4) [back to overview]Change From Baseline in Target Lesion Assessment
NCT01445886 (3) [back to overview]Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail
NCT01445886 (3) [back to overview]Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks
NCT01445886 (3) [back to overview]Physician's and Subject's Global Assessment
NCT01536886 (1) [back to overview]Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
NCT01536938 (1) [back to overview]Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
NCT01580488 (6) [back to overview]Change in Lesion Thickness From Baseline to Day 22
NCT01580488 (6) [back to overview]Change in Infiltration From Baseline to Day 22
NCT01580488 (6) [back to overview]Change in Erythema From Baseline to Day 22
NCT01580488 (6) [back to overview]Change in the Total Clinical Score From Baseline to Day 22
NCT01580488 (6) [back to overview]Change in Scaling From Baseline to Day 22
NCT01580488 (6) [back to overview]Change in Skin Thickness From Baseline to Day 22
NCT01694433 (2) [back to overview]Lesion Counts (Total, Inflammatory and Non-inflammatory)
NCT01694433 (2) [back to overview]Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
NCT01707043 (2) [back to overview]Subjective Subject Preference Survey for the First Treatment Session
NCT01707043 (2) [back to overview]Subjective Subject Preference Survey for the Second Treatment Session
NCT01745133 (1) [back to overview]Physician Global Assessement
NCT02132936 (5) [back to overview]Treatment Success According to the PGA
NCT02132936 (5) [back to overview]Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.
NCT02132936 (5) [back to overview]Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).
NCT02132936 (5) [back to overview]Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).
NCT02132936 (5) [back to overview]Time to 'Treatment Success' According to PGA.
NCT02193815 (9) [back to overview]Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12
NCT02193815 (9) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs
NCT02193815 (9) [back to overview]Number of Participants With Potentially Clinically Significant Vital Signs Findings
NCT02193815 (9) [back to overview]Global Clinical Assessment at Day 1, 8 and 12
NCT02193815 (9) [back to overview]Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB
NCT02193815 (9) [back to overview]Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12
NCT02193815 (9) [back to overview]Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
NCT02193815 (9) [back to overview]Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
NCT02193815 (9) [back to overview]Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8
NCT02858713 (3) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02858713 (3) [back to overview]Lattice-System Physician's Global Assessment (LS-PGA)
NCT02858713 (3) [back to overview]Percentage of Adherent Participants
NCT02878382 (4) [back to overview]Change From Baseline in Fluorescence Intensity of PPIX
NCT02878382 (4) [back to overview]Changes From Baseline in Actinic Keratosis - Lesion Base Count.
NCT02878382 (4) [back to overview]Percentage of Actinic Keratosis (AK) Lesions Cleared
NCT02878382 (4) [back to overview]Pain Scores Immediately Post Illumination
NCT03441789 (6) [back to overview]Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
NCT03441789 (6) [back to overview]Percent of Subjects With PASI 75 at Week 4 and Week 12
NCT03441789 (6) [back to overview]Percent of Subjects With PASI 90 and 100 at Week 16
NCT03441789 (6) [back to overview]Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
NCT03441789 (6) [back to overview]Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
NCT03441789 (6) [back to overview]Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
NCT03469336 (8) [back to overview]Number of Participants With Treatment-emergent Adverse Events (AEs)
NCT03469336 (8) [back to overview]Area Under the Curve of the Psoriatic Skin Infiltrate Thickness
NCT03469336 (8) [back to overview]Change From Baseline in Psoriatic Skin Infiltrate Thickness
NCT03469336 (8) [back to overview]Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria
NCT03469336 (8) [back to overview]Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
NCT03469336 (8) [back to overview]Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
NCT03469336 (8) [back to overview]Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.
NCT03469336 (8) [back to overview]Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.
NCT03848871 (6) [back to overview]Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
NCT03848871 (6) [back to overview]Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
NCT03848871 (6) [back to overview]Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
NCT03848871 (6) [back to overview]Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
NCT03848871 (6) [back to overview]Change in Lesion Size From Baseline to Week 2 and Week 4
NCT03848871 (6) [back to overview]Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4

Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.

PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Median)
Adalimumab + Placebo-100.00
Adalimumab + Calcipotriol/Betamethasone-100.00

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Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.

NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Median)
Adalimumab + Placebo-40.00
Adalimumab + Calcipotriol/Betamethasone-37.50

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Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)

PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo50.3
Adalimumab + Calcipotriol/Betamethasone38.8

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Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)

Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Mean)
Adalimumab + Placebo20.53
Adalimumab + Calcipotriol/Betamethasone19.71

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Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)

Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%. (NCT00574249)
Timeframe: Week 0 and Week 8

Interventionpercent change in score (Mean)
Adalimumab + Placebo19.35
Adalimumab + Calcipotriol/Betamethasone18.22

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Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 2

Interventionpercent change in score (Mean)
Adalimumab + Placebo-32.14
Adalimumab + Calcipotriol/Betamethasone-47.49

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Adalimumab + Placebo64.8
Adalimumab + Calcipotriol/Betamethasone50.0

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 12

Interventionpercent change in score (Mean)
Adalimumab + Placebo-69.49
Adalimumab + Calcipotriol/Betamethasone-66.75

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 2

Interventionpercentage of participants (Number)
Adalimumab + Placebo7.1
Adalimumab + Calcipotriol/Betamethasone13.9

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Adalimumab + Placebo24.5
Adalimumab + Calcipotriol/Betamethasone33.1

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Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Adalimumab + Placebo46.2
Adalimumab + Calcipotriol/Betamethasone42.9

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Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16

PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). (NCT00574249)
Timeframe: Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo64.6
Adalimumab + Calcipotriol/Betamethasone56.6

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Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)

PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo70.9
Adalimumab + Calcipotriol/Betamethasone64.8

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Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)

PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo24.2
Adalimumab + Calcipotriol/Betamethasone15.3

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Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)

PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercentage of participants (Number)
Adalimumab + Placebo82.7
Adalimumab + Calcipotriol/Betamethasone80.9

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 16

Interventionpercent change in score (Mean)
Adalimumab + Placebo-71.46
Adalimumab + Calcipotriol/Betamethasone-67.20

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 4

Interventionpercent change in score (Mean)
Adalimumab + Placebo-46.64
Adalimumab + Calcipotriol/Betamethasone-60.93

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Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)

DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. (NCT00574249)
Timeframe: Week 0 and Week 8

Interventionpercent change in score (Mean)
Adalimumab + Placebo-63.30
Adalimumab + Calcipotriol/Betamethasone-62.30

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Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8

(NCT00640822)
Timeframe: Week 8

InterventionParticipants (Number)
Calcipotriol Plus Hydrocortisone Ointment183
Tacalcitol Ointment147
Calcipotriol Plus Hydrocortisone Ointment Vehicle37

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Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer

Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes (NCT00656019)
Timeframe: 10 days to 4 weeks post diagnosis.

Interventionpercentage of participants (Number)
Normal Vitamin D Levels0
Low-normal Vitamin D Levels0
Low Vitamin D Levels0
Very-low Vitamin D Levels0

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Subjects With Relapse During the Study

Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit (NCT00670241)
Timeframe: Week 8-16

Interventionparticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel28
Tacalcitol Ointment7
Gel Vehicle3

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Subjects With Rebound During the Study

(NCT00670241)
Timeframe: Week 8-16

Interventionparticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel0
Tacalcitol Ointment0
Gel Vehicle0

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"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"

(NCT00670241)
Timeframe: Week 4

Interventionparticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel34
Tacalcitol Ointment12
Gel Vehicle1

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The Percentage Change in PASI From Baseline to Week 8

PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst). (NCT00670241)
Timeframe: Baseline, Week 4 and 8

InterventionPercent change in PASI score (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel-57.0
Tacalcitol Ointment-41.9
Gel Vehicle-17.9

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"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"

(NCT00670241)
Timeframe: Week 8

InterventionParticipants (Number)
Calcipotriol Plus Betamethasone Dipropionate Gel73
Tacalcitol Ointment33
Gel Vehicle5

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"Participants With Success According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase"

"Success was defined as a TSS score of 0 or 1.~For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below:~Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured)~The sum of the three scores constituted a TSS ranging from 0 to 12" (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)

InterventionParticipants (Count of Participants)
LEO 80190171
Calcipotriol136
Hydrocortisone131
LEO 80190 Vehicle42

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"Participants With Success According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase"

"The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face.~For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below:~Redness 0 = none~= mild~= moderate~= severe~= very severe~Thickness 0 = none~= mild~= moderate~= severe~= very severe~Scaliness 0 = none~= mild~= moderate~= severe~= very severe~A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS.~Success was defined as a TSS score of 0 or 1." (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)

InterventionParticipants (Count of Participants)
LEO 8019082
Calcipotriol81
Hydrocortisone59
LEO 80190 Vehicle15

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"Participants With Controlled Disease According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase"

"The assessment of the disease severity of the face was made using the 6-category scale below.~Clear Almost clear Mild Moderate Severe Very severe~The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit.~For subjects with a baseline severity of moderate or worse - controlled disease of the face was defined as clear or almost clear according to the IGA of disease severity of the face.~For subjects with a baseline severity of mild - controlled disease of the face was defined as clear according to the IGA of disease severity of the face." (NCT00691002)
Timeframe: At Week 4

InterventionParticipants (Count of Participants)
LEO 80190101
Calcipotriol66
Hydrocortisone61
LEO 80190 Vehicle14

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"Participants With Controlled Disease According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase"

"The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below.~Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit.~For subjects with a baseline severity of moderate or worse - controlled disease of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas.~For subjects with a baseline severity of mild - controlled disease of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas." (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)

InterventionParticipants (Count of Participants)
LEO 8019080
Calcipotriol55
Hydrocortisone48
LEO 80190 Vehicle14

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"Participants With Controlled Disease According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase"

"The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.~Clear, Almost clear, Mild, Moderate, Severe, Very severe~The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit.~For subjects with a baseline (Visit 1) severity of moderate or worse - controlled disease of the face was defined as clear or almost clear according to the IGA of disease severity of the face.~For subjects with a baseline (Visit 1) severity of mild - controlled disease of the face was defined as clear according to the IGA of disease severity of the face." (NCT00691002)
Timeframe: At Week 8 (end of treatment for double-blind phase)

InterventionParticipants (Count of Participants)
LEO 80190158
Calcipotriol135
Hydrocortisone115
LEO 80190 Vehicle41

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Serum Cortisol Concentration After 30 Minutes

The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. (NCT00704262)
Timeframe: At Week 4 and Week 8

Interventionmcg/dL (Mean)
Week 4 (Day 28)Week 8 (Day 56)
Calcipotriol Plus Hydrocortisone (LEO 80190)25.2925.93

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Overall Disease Severity of the Face According to the IGA

6-category scale based on plaque thickening (P), Scaling (S), Erythema (E). Clear (P=no elevation/thickening of normal skin, S=no evidence of scaling, E=none/hyperpigmentation/residual red coloration) Almost clear (P=none/possible thickening but difficult to ascertain whether there is a slight elevation above normal skin level, S=none/residual surface dryness and scaling, E=light pink coloration) Mild (P=slight but definite elevation, S=fine scales partially/mostly covering lesions, E=light red coloration) Moderate (P=moderate elevation with rounded or sloped edges, S=most lesions at least partially covered, E=definite red coloration) Severe (P =marked elevation typically with hard or sharp edges, S=non-tenacious scale predominates, covering most or all of the lesions, E=very bright red coloration) Very severe (P=very marked elevation typically with hard or sharp edges, S=thick tenacious scale covers most or all of the lesions, E=extreme red coloration, deep red coloration) (NCT00704262)
Timeframe: At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)

InterventionParticipants (Count of Participants)
Baseline72237955Week 2 (Day 14)72237955Week 4 (Day 28)72237955Week 6 (Day 42)72237955Week 8 (Day 56)72237955End of Treatment (last value recorded)72237955
MildModerateSevereVery severeClearAlmost clear
Calcipotriol Plus Hydrocortisone (LEO 80190)27
Calcipotriol Plus Hydrocortisone (LEO 80190)12
Calcipotriol Plus Hydrocortisone (LEO 80190)16
Calcipotriol Plus Hydrocortisone (LEO 80190)9
Calcipotriol Plus Hydrocortisone (LEO 80190)2
Calcipotriol Plus Hydrocortisone (LEO 80190)1
Calcipotriol Plus Hydrocortisone (LEO 80190)0
Calcipotriol Plus Hydrocortisone (LEO 80190)5
Calcipotriol Plus Hydrocortisone (LEO 80190)15
Calcipotriol Plus Hydrocortisone (LEO 80190)7
Calcipotriol Plus Hydrocortisone (LEO 80190)14
Calcipotriol Plus Hydrocortisone (LEO 80190)6
Calcipotriol Plus Hydrocortisone (LEO 80190)3

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Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range

"The table summarizes the shifts in albumin corrected serum calcium versus the normal range. The end of treatment data was defined as the last value recorded for the parameter during the treatment phase of the study (i.e. Week 4, 6, or 8).~The normal reference range for the albumin corrected serum calcium was defined as 2.1-2.64 mmol/L (8.4-10.6 mg/L). The value below this level was considered 'low', while the value above this range was considered 'high'." (NCT00704262)
Timeframe: At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)

InterventionParticipants (Count of Participants)
Week 2 (Day 14)72237955Week 4 (Day 28)72237955Week 6 (Day 42)72237955Week 8 (Day 56)72237955End of Treatment (last value recorded)72237955
LowNormalHigh
Calcipotriol Plus Hydrocortisone (LEO 80190)30
Calcipotriol Plus Hydrocortisone (LEO 80190)3
Calcipotriol Plus Hydrocortisone (LEO 80190)2
Calcipotriol Plus Hydrocortisone (LEO 80190)26
Calcipotriol Plus Hydrocortisone (LEO 80190)0
Calcipotriol Plus Hydrocortisone (LEO 80190)6
Calcipotriol Plus Hydrocortisone (LEO 80190)21
Calcipotriol Plus Hydrocortisone (LEO 80190)27

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"Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face"

Controlled disease was defined as the following (P=Plaque thickening, S=Scaling, E=Erythema) Clear (Plaque thickening=no elevation/thickening of normal skin, S=no evidence of scaling, E= none/hyperpigmentation/residual red coloration) or Almost clear (P=none/possible thickening but difficult to ascertain whether there is a slight elevation above normal skin level, S=none/residual surface dryness and scaling, E=light pink coloration) (last value recorded i.e. Week 4, 6, or 8) (NCT00704262)
Timeframe: At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)

InterventionParticipants (Count of Participants)
Week 4 (Day 28)72237955Week 8 (Day 56)72237955End of Treatment (last value recorded)72237955
ControlledNon-controlled
Calcipotriol Plus Hydrocortisone (LEO 80190)21
Calcipotriol Plus Hydrocortisone (LEO 80190)12
Calcipotriol Plus Hydrocortisone (LEO 80190)19
Calcipotriol Plus Hydrocortisone (LEO 80190)9
Calcipotriol Plus Hydrocortisone (LEO 80190)23
Calcipotriol Plus Hydrocortisone (LEO 80190)10

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"Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas"

"Controlled disease was defined as the following:~Clear (Infiltration = no elevation or thickening of normal skin, Erythema = normal skin colour or hyperpigmentation) or Almost clear (Infiltration = no elevation or thickening of normal skin, Erythema = faint pink colour) The end of treatment data was defined as the last value recorded for the efficacy measure." (NCT00704262)
Timeframe: At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)

InterventionParticipants (Count of Participants)
Week 4 (Day 28)72237955Week 8 (Day 56)72237955End of Treatment (last value recorded)72237955
ControlledNon-controlled
Calcipotriol Plus Hydrocortisone (LEO 80190)20
Calcipotriol Plus Hydrocortisone (LEO 80190)13
Calcipotriol Plus Hydrocortisone (LEO 80190)19
Calcipotriol Plus Hydrocortisone (LEO 80190)9
Calcipotriol Plus Hydrocortisone (LEO 80190)23
Calcipotriol Plus Hydrocortisone (LEO 80190)10

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The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes

"The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin.~≤18 mcg/dL was considered low." (NCT00704262)
Timeframe: At Week 4 and Week 8

InterventionParticipants (Count of Participants)
>18 mcg/dL≤18 mcg/dL
Calcipotriol Plus Hydrocortisone (LEO 80190)300

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The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes

"The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin.~≤18 mcg/dL was considered low." (NCT00704262)
Timeframe: At Week 4 and Week 8

InterventionParticipants (Count of Participants)
>18 mcg/dL≤18 mcg/dL
Calcipotriol Plus Hydrocortisone (LEO 80190)291

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The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes

"The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin.~≤18 mcg/dL was considered low." (NCT00704262)
Timeframe: At Week 4 (Day 28) and Week 8 (Day 56)

InterventionParticipants (Count of Participants)
>18 mcg/dL≤18 mcg/dL
Calcipotriol Plus Hydrocortisone (LEO 80190)291

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Overall Disease Severity of Intertriginous Areas According to the IGA

"The assessment of the disease severity of the intertriginous areas was made using the 6-category scale; clear, almost clear, mild, moderate, severe, very severe.~Clear (Infiltration = no elevation or thickening of normal skin, Erythema = normal skin colour or hyperpigmentation) Almost clear (Infiltration = no elevation or thickening of normal skin, Erythema = faint pink colour) Mild (Infiltration = slight, subtle thickening or infiltration, only marginally increased from normal skin, Erythema = light pink colour) Moderate (Infiltration = palpable thickening or infiltration without elevation, Erythema = definite pink colour) Severe (Infiltration = palpable thickening or infiltration with elevation, Erythema = very bright red coloration) Very severe (Infiltration = marked thickening or infiltration with rounded or sloped edges, Erythema = bright deep red coloration)" (NCT00704262)
Timeframe: At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)

InterventionParticipants (Count of Participants)
Baseline72237955Week 2 (Day 14)72237955Week 4 (Day 28)72237955Week 6 (Day 42)72237955Week 8 (Day 56)72237955End of Treatment (last value recorded)72237955
Almost clearMildClearVery severeModerateSevere
Calcipotriol Plus Hydrocortisone (LEO 80190)0
Calcipotriol Plus Hydrocortisone (LEO 80190)19
Calcipotriol Plus Hydrocortisone (LEO 80190)12
Calcipotriol Plus Hydrocortisone (LEO 80190)7
Calcipotriol Plus Hydrocortisone (LEO 80190)16
Calcipotriol Plus Hydrocortisone (LEO 80190)9
Calcipotriol Plus Hydrocortisone (LEO 80190)15
Calcipotriol Plus Hydrocortisone (LEO 80190)4
Calcipotriol Plus Hydrocortisone (LEO 80190)17
Calcipotriol Plus Hydrocortisone (LEO 80190)5
Calcipotriol Plus Hydrocortisone (LEO 80190)2
Calcipotriol Plus Hydrocortisone (LEO 80190)10
Calcipotriol Plus Hydrocortisone (LEO 80190)13
Calcipotriol Plus Hydrocortisone (LEO 80190)1

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Serum Cortisol Concentration After 60 Minutes

The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. (NCT00704262)
Timeframe: At Week 4 and Week 8

Interventionmcg/dL (Mean)
Week 4 (Day 28)Week 8 (Day 56)
Calcipotriol Plus Hydrocortisone (LEO 80190)28.8128.82

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Albumin Corrected Serum Calcium

The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). (NCT00704262)
Timeframe: At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)

Interventionmmol/L (Mean)
Week 2 (Day 14)Week 4 (Day 28)Week 6 (Day 42)Week 8 (Day 56)End of Treatment (last value recorded)
Calcipotriol Plus Hydrocortisone (LEO 80190)2.2332.2172.2082.1792.182

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Change in Albumin Corrected Serum Calcium

Baseline was defined as the last assessment performed before study medication application. (NCT00704262)
Timeframe: From baseline to Week 2 and Week 6

Interventionmmol/L (Mean)
BaselineWeek 2 (Day 14)Week 6 (Day 42)
Calcipotriol Plus Hydrocortisone (LEO 80190)2.2150.018-0.013

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Change in Albumin Corrected Serum Calcium

Baseline was defined as the last assessment performed before study medication application. The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). (NCT00704262)
Timeframe: From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)

Interventionmmol/L (Mean)
BaselineWeek 4 (Day 28)Week 8 (Day 56)End of Treatment (last value recorded)
Calcipotriol Plus Hydrocortisone (LEO 80190)2.2150.002-0.045-0.033

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The Absolute Change in PASI (Psoriasis Area Severity Index)

"The following formula was used to calculate the PASI for each side of the body:~Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z~where: R = score for redness T = score for thickness S = score for scaliness E = score for extent~The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here." (NCT00764751)
Timeframe: From baseline to end of treatment (Day 28)

Interventionunits on a scale (Mean)
Group A: LEO 19123-2.6
Group A: Dovonex®-3.8
Group B: LEO 19123-4.2
Group B: LEO 19123 Vehicle-2.5

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The Percentage Change in PASI (Psoriasis Area Severity Index)

"The following formula was used to calculate the PASI for each side of the body:~Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z~where: R = score for redness T = score for thickness S = score for scaliness E = score for extent~The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here." (NCT00764751)
Timeframe: From baseline (Day 0) to end of treatment (Day 28)

Interventionpercentage change in PASI (Mean)
Group A: LEO 19123-24.8
Group A: Dovonex®-40.2
Group B: LEO 19123-46.8
Group B: LEO 19123 Vehicle-29.8

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Participant's Overall Assessment of Treatment Response

"The participant assessed the treatment response by use of the 6-point scale below.~Worse Unchanged Slight improvement Moderate improvement Marked improvement Almost clear Cleared" (NCT00764751)
Timeframe: At end of treatment (Day 28)

,,,
InterventionParticipants (Count of Participants)
WorseUnchangedSlight improvementModerate improvementMarked improvementAlmost clearClear
Group A: Dovonex®149121200
Group A: LEO 19123291212300
Group B: LEO 191231315200
Group B: LEO 19123 Vehicle0371100

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Participant's Assessment of Treatment Preference

(NCT00764751)
Timeframe: At end of treatment (Day 28)

,
InterventionParticipants (Count of Participants)
LEO 19123No preferenceReference product
Group A51221
Group B633

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Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.

(NCT00817219)
Timeframe: Baseline and 4 Weeks

Interventionmmol/g (Mean)
TACLONEX Ointment0.717

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Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment

The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment0

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Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment

The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment0

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PASI 75 at Week 4.

PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here. (NCT00817219)
Timeframe: 4 weeks

Interventionparticipants (Number)
TACLONEX Ointment17

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PASI 50 at Week 4.

PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment28

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Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment

(NCT00817219)
Timeframe: Baseline and 4 weeks

Interventionmmol/L (Mean)
TACLONEX Ointment0.005

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Adverse Drug Reactions

"The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as not related." (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment2

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"Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4."

The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe). (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment23

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"Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4."

The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs. (NCT00817219)
Timeframe: Week 4

Interventionparticipants (Number)
TACLONEX Ointment20

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Percentage Change in PASI From Baseline to Week 4.

PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here. (NCT00817219)
Timeframe: Baseline and 4 weeks

Interventionpercentage (Mean)
TACLONEX Ointment-72.5

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Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline

The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe). (NCT00820950)
Timeframe: Baseline, Days 8, 15, 22, 28 and 56

,,,,,,,,,
InterventionScore on Scale (Mean)
Day 8Day 15Day 22Day 28Day 56/ET
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream-1.3-1.3-2.2-1.0-1.3
Part 1 Cohort A: Vehicle-1.3-1.3-1.4-1.2-1.5
Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream-1.7-2.0-3.0-3.80.5
Part 1 Cohort B: Vehicle-1.0-1.3-1.8-2.20.5
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream-3.2-3.0-3.5-3.7-2.0
Part 1 Cohort C: Vehicle Cream-1.7-1.7-1.7-2.2-1.8
Part 2 Cohort D: INCB18424-2.4-2.0-3.6-3.4-3.2
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)-2.2-2.2-2.6-3.2-3.0
Part 2 Cohort E: INCB18424-2.3-2.4-3.2-3.00.0
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)-2.8-3.0-3.4-4.2-1.4

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Change in Target Lesion Area Compared to Baseline

Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area. (NCT00820950)
Timeframe: Day 28

Interventioncm^2 (Mean)
Cohort A: Vehicle0.35
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream1.53
Cohort B: Vehicle0.45
Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle-3.18
Cohort C: Vehicle-4.03
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream-11.45
Cohort D: INCB18424-5.22
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)-2.54
Cohort E: INCB184241.53
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)-0.48

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Number of Participants With Treatment Emergent Adverse Events

A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug. (NCT00820950)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream6
Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle1
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream5
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)4
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)2

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Pharmacokinetics Parameter : Bioavailability of INCB018424

The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. (NCT00820950)
Timeframe: Days 8, 15, 22, and 28

InterventionPercentage of dosage (Mean)
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream2.8
Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle3.0
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream3.0
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)2.7
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)2.7

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Pharmacokinetics Parameter : Skin Flux of INCB018424

The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant. (NCT00820950)
Timeframe: Days 8, 15, 22, and 28

Interventionng/cm^2/h (Mean)
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream54.2
Part 1 Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle151
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream422
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)363
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)383

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Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline

The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe). (NCT00820950)
Timeframe: Baseline, Days 8, 15, 22, 28 and 56

,,,,,,,,,
InterventionScores on a scale (Mean)
Day 8 - ErythemaDay 8 - ScalingDay 8 - ThicknessDay 15 - ErythemaDay 15 - ScalingDay 15 - ThicknessDay 22 - ErythemaDay 22 - ScalingDay 22 - ThicknessDay 28 - ErythemaDay 28 - ScalingDay 28 - ThicknessDay 56/ET - ErythemaDay 56/ET - ScalingDay 56/ET - Thickness
Part 1 Cohort A: Ruxolitinib 0.5% Cream-0.5-0.2-0.7-0.7-0.3-0.3-1.0-0.6-0.6-0.4-0.4-0.2-0.3-0.2-0.3
Part 1 Cohort A: Vehicle Cream-0.5-0.2-0.7-0.7-0.3-0.3-0.8-0.4-0.2-0.6-0.2-0.4-0.5-0.2-0.3
Part 1 Cohort B: Ruxolitinib 1.0% Cream-1.0-0.2-0.3-1.0-0.3-0.3-1.5-0.8-0.5-1.7-1.0-1.0-0.20.70.2
Part 1 Cohort B: Vehicle Cream-0.80.0-0.2-0.8-0.2-0.2-1.0-0.5-0.3-1.2-0.7-0.30.00.30.0
Part 1 Cohort C: Ruxolitinib 1.5% Cream-1.2-1.2-0.8-1.2-1.0-0.8-1.2-1.2-1.2-1.0-1.2-1.5-0.5-0.7-0.8
Part 1 Cohort C: Vehicle Cream-0.7-0.7-0.3-0.5-0.7-0.5-0.3-0.5-0.8-0.5-0.5-1.2-0.5-0.7-0.7
Part 2 Cohort D: Calcipotriene (Dovonex®)-0.8-0.6-0.6-0.8-0.4-0.8-1.0-0.6-0.8-1.2-0.8-1.0-1.2-0.7-1.0
Part 2 Cohort D: INCB18424-1.2-0.6-0.4-1.0-0.2-0.6-1.8-0.6-1.0-1.4-0.8-1.0-1.0-0.8-1.2
Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF)-1.3-0.8-0.8-1.2-1.2-0.6-1.6-1.0-0.8-1.8-1.2-1.2-0.6-0.4-0.4
Part 2 Cohort E: INCB18424-1.0-0.8-0.5-1.0-0.8-0.6-1.4-0.8-1.0-1.2-0.8-1.00.2-0.20.0

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Change in Infiltration Compared to Baseline

"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration" (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

,,,,,
Interventionunits on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.10-0.38-0.77-0.98-1.10-1.25-1.35
Daivobet® Ointment-0.29-0.79-1.29-1.79-1.94-1.98-2.02
LEO 29102 Cream-0.04-0.13-0.31-0.42-0.58-0.56-0.73
LEO 29102 Cream Vehicle-0.06-0.06-0.13-0.25-0.33-0.31-0.38
LEO 29102 Plus Betamethasone Dipropionate-0.27-0.73-1.06-1.35-1.50-1.67-1.67
LEO 29102 Plus Calcipotriol Cream0.00-0.29-0.46-0.69-0.75-0.90-1.06

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Biomarkers by Immunochemistry

"3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.~Cells counted per mm^2 were cells that were positive for the indicated biomarker." (NCT00875277)
Timeframe: At end of treatment

,,,,,
Interventioncells/mm^2 (Mean)
Macrophages: CD163Dendritic cells CD1aT-cell biomarker CD3Angiogenesis: CD31T-cell biomarker: CD4T-cell biomarker: CD45ROMacrophages: CD68T-cell biomarker: CD8
Betamethasone Dipropionate Cream197.442.14124.5216.359.17101.6120.360.05
Daivobet® Ointment172.956.34143.9186.666.95218.2156.865.05
LEO 29102 Cream291.2229.3464.2331.1246.4630.1323.1220.7
LEO 29102 Cream Vehicle313.9233.8593.8430.7284.3752.0370.8280.5
LEO 29102 Plus Betamethasone Dipropionate178.234.31126.1184.255.56121.6142.166.35
LEO 29102 Plus Calcipotriol Cream383.5244.0492.7348.8239.0643.6303.8253.2

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Pathology and Histology by Treatment: Epidermal Thickness

Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections.. (NCT00875277)
Timeframe: At end of treatment

Interventionµm (Mean)
LEO 29102 Cream Vehicle254.6
Betamethasone Dipropionate Cream73.81
LEO 29102 Cream187.5
LEO 29102 Plus Calcipotriol Cream176.4
LEO 29102 Plus Betamethasone Dipropionate68.48
Daivobet® Ointment66.90

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Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses

"Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study.~In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections." (NCT00875277)
Timeframe: At end of treatment

Interventioncells/mm^2 (Mean)
LEO 29102 Cream Vehicle0.14
Betamethasone Dipropionate Cream0.00
LEO 29102 Cream0.15
LEO 29102 Plus Calcipotriol Cream0.17
LEO 29102 Plus Betamethasone Dipropionate0.00
Daivobet® Ointment0.05

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Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)

"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration~The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)." (NCT00875277)
Timeframe: From baseline (Day 1) to end of treatment (Day 29)

Interventionscore on a scale (Mean)
LEO 29102 Cream Vehicle-1.60
Betamethasone Dipropionate Cream-4.96
LEO 29102 Cream-3.04
LEO 29102 Plus Calcipotriol Cream-3.96
LEO 29102 Plus Betamethasone Dipropionate-5.56
Daivobet® Ointment-6.10

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Biomarkers by Immunochemistry: Epidermal Proliferation

"3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.~By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker." (NCT00875277)
Timeframe: At end of treatment

Interventioncells/mm^2 (Mean)
LEO 29102 Cream Vehicle554.1
Betamethasone Dipropionate Cream19.45
LEO 29102 Cream443.3
LEO 29102 Plus Calcipotriol Cream354.3
LEO 29102 Plus Betamethasone Dipropionate20.50
Daivobet® Ointment93.49

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Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound

The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment. (NCT00875277)
Timeframe: At Day 8, Day 15, Day 22 and end of treatment

,,,,,
Interventionmm (Mean)
Visit 8 (Day 8)Visit 14 (Day 15)Visit 20 (Day 22)Visit 26 (Day 29)
Betamethasone Dipropionate Cream-0.14-0.45-0.54-0.63
Daivobet® Ointment-0.39-0.68-0.68-0.78
LEO 29102 Cream0.03-0.16-0.15-0.30
LEO 29102 Cream Vehicle0.05-0.05-0.07-0.13
LEO 29102 Plus Betamethasone Dipropionate-0.30-0.51-0.57-0.68
LEO 29102 Plus Calcipotriol Cream0.00-0.25-0.24-0.38

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Pathology and Histology by Treatment

"Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:~Morphology of epidermis~Stratum corneum (semi (extent of))~Stratum granulosum (semi (extent of))~Parakeratosis (semi (extent of))~Infiltration of inflammatory cells (semi (extent of))" (NCT00875277)
Timeframe: At end of treatment

,,,,,
Interventionscore on a scale (Mean)
Infiltration of inflammatory cellsParakeratosisStratum CorneumStratum Granulosum
Betamethasone Dipropionate Cream0.170.000.330.17
Daivobet® Ointment0.670.170.330.17
LEO 29102 Cream1.521.391.521.04
LEO 29102 Cream Vehicle1.501.671.831.42
LEO 29102 Plus Betamethasone Dipropionate0.500.000.500.00
LEO 29102 Plus Calcipotriol Cream1.531.351.411.00

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Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline

"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration~The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)." (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

,,,,,
Interventionscore on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.63-1.92-2.85-3.54-4.00-4.27-4.71
Daivobet® Ointment-1.19-2.85-4.40-5.23-5.69-6.02-6.17
LEO 29102 Cream-0.19-0.88-1.40-1.75-2.23-2.21-2.75
LEO 29102 Cream Vehicle-0.27-0.42-0.75-1.17-1.42-1.31-1.54
LEO 29102 Plus Betamethasone Dipropionate-1.00-2.81-3.71-4.48-5.04-5.17-5.50
LEO 29102 Plus Calcipotriol Cream-0.29-1.21-1.60-2.46-2.88-3.21-3.60

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Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline

"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)." (NCT00875277)
Timeframe: From baseline (Day 1) to end of treatment (Day 29)

,,,,,
Interventionscore on a scale (Mean)
ErythemaInfiltrationScaliness
Betamethasone Dipropionate Cream-1.71-1.46-1.79
Daivobet® Ointment-1.88-2.04-2.19
LEO 29102 Cream-0.90-0.85-1.29
LEO 29102 Cream Vehicle-0.42-0.46-0.73
LEO 29102 Plus Betamethasone Dipropionate-1.85-1.75-1.96
LEO 29102 Plus Calcipotriol Cream-1.19-1.17-1.60

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Change in Scaling Compared to Baseline

"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales" (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

,,,,,
Interventionunits on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.31-0.88-1.15-1.33-1.56-1.54-1.81
Daivobet® Ointment-0.52-1.19-1.92-2.04-2.13-2.19-2.21
LEO 29102 Cream-0.13-0.44-0.63-0.73-0.90-0.81-1.17
LEO 29102 Cream Vehicle-0.17-0.27-0.40-0.52-0.65-0.54-0.75
LEO 29102 Plus Betamethasone Dipropionate-0.33-1.17-1.48-1.67-1.83-1.75-2.00
LEO 29102 Plus Calcipotriol Cream-0.21-0.63-0.71-1.00-1.15-1.27-1.46

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Change in Erythema Compared to Baseline

"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red" (NCT00875277)
Timeframe: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25

,,,,,
Interventionunits on a scale (Mean)
Visit 5 (Day 4)Visit 8 (Day 8)Visit 11 (Day 11)Visit 14 (Day 15)Visit 17 (Day 18)Visit 20 (Day 22)Visit 23 (Day 25)
Betamethasone Dipropionate Cream-0.21-0.67-0.94-1.23-1.33-1.48-1.54
Daivobet® Ointment-0.38-0.88-1.19-1.40-1.63-1.85-1.94
LEO 29102 Cream-0.02-0.31-0.46-0.60-0.75-0.83-0.85
LEO 29102 Cream Vehicle-0.04-0.08-0.23-0.40-0.44-0.46-0.42
LEO 29102 Plus Betamethasone Dipropionate-0.40-0.92-1.17-1.46-1.71-1.75-1.83
LEO 29102 Plus Calcipotriol Cream-0.08-0.29-0.44-0.77-0.98-1.04-1.08

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Biomarkers by Immunochemistry: Epidermal Differentiation

3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement. (NCT00875277)
Timeframe: At end of treatment

,,,,,
Intervention%, positive area/total area (Mean)
Epidermal differentiation: CK10Epidermal differentiation: CK16
Betamethasone Dipropionate Cream0.890.00
Daivobet® Ointment0.890.00
LEO 29102 Cream0.770.08
LEO 29102 Cream Vehicle0.760.11
LEO 29102 Plus Betamethasone Dipropionate0.930.01
LEO 29102 Plus Calcipotriol Cream0.750.02

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Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8

Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration. (NCT01139580)
Timeframe: Baseline and Week 8

Interventionparticipants (Number)
Calcipotriene Foam42
Vehicle Foam30

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Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8

The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions. (NCT01139580)
Timeframe: Week 8

,
Interventionparticipants (Number)
Failure methodLOCF
Calcipotriene Foam3233
Vehicle Foam2828

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Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer. (NCT01139580)
Timeframe: Week 8

Interventionparticipants (Number)
Calcipotriene Foam75
Vehicle Foam45

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Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method

The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer. (NCT01139580)
Timeframe: Week 8

Interventionparticipants (Number)
Calcipotriene Foam74
Vehicle Foam44

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Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8

Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates. (NCT01139580)
Timeframe: Baseline and Week 8

Interventionparticipants (Number)
Calcipotriene Foam53
Vehicle Foam38

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Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8

Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges. (NCT01139580)
Timeframe: Baseline and Week 8

Interventionparticipants (Number)
Calcipotriene Foam67
Vehicle Foam53

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Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4

The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline. (NCT01188928)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 8018564
Betamethasone60
Calcipotriol5
Topical Suspension Vehicle2

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Mean Percentage Change in PASI From Baseline to Week 8

At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72. (NCT01188928)
Timeframe: Baseline and 8 weeks

Interventionpercentage of change in PASI (Mean)
LEO 80185-55.8
Betamethasone-48.6
Calcipotriol-43.6
Topical Suspension Vehicle-20.9

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Mean Percentage Change in PASI From Baseline to Week 4

At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72. (NCT01188928)
Timeframe: Baseline and 4 weeks

Interventionpercentage of change in PASI (Mean)
LEO 80185-46.4
Betamethasone-42.7
Calcipotriol-32.2
Topical Suspension Vehicle-17.4

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Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8

The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline. (NCT01188928)
Timeframe: week 8

Interventionparticipants (Number)
LEO 80185140
Betamethasone103
Calcipotriol14
Topical Suspension Vehicle6

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Patients With Success (Total Sign Score ≤1) at Week 4

"Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved Success." (NCT01195831)
Timeframe: 4 weeks

Interventionpercentage of participants (Number)
Xamiol® Gel64.2
Calcipotriol Scalp Solution25.8

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"Patients With Controlled Disease in Terms of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 2."

Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments. (NCT01195831)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Xamiol® Gel79.2
Calcipotriol Scalp Solution37.1

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"Patients With Controlled Disease in Terms of Clear or Minimal According to Investigator's Global Assessment of Disease Severity at Week 4."

Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease. (NCT01195831)
Timeframe: 4 weeks

Interventionpercentage of parcipitants (Number)
Xamiol® Gel87.5
Calcipotriol Scalp Solution50.8

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"Patients With Controlled Disease in Terms of Clear or Minimal According to Investigator's Global Assessment of Disease Severity at Week 2"

Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease. (NCT01195831)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Xamiol® Gel80.8
Calcipotriol Scalp Solution25.8

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"Patients With Controlled Disease in Term of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 4."

Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments. (NCT01195831)
Timeframe: 4 weeks

Interventionpercentage of participants (Number)
Xamiol® Gel90.8
Calcipotriol Scalp Solution60.5

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Overview of Treatment-Emergent Adverse Events (TEAEs)

TEAEs were defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (baseline), or re-emerged during treatment, having been present at baseline but stopped prior to treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. Safety variables included TEAEs including skin reactions, diascopy and biopsy findings, clinical laboratory parameters, vital signs, and physical examinations. For Cohort 2, special attention was given to a close, daily monitoring of the application site for signs of skin irritation. Any suspected ecchymoses or petechiae were to be followed up with a diascopy test that was to be documented with digital photographs. Any positive diascopy test was to be followed up by biopsy for skin ultrastructural analysis (if agreed to by the participant, sponsor, and investigator). Few adverse events occurred in more than one treatment group. (NCT01268527)
Timeframe: From first dose of study treatment up to 30 days after the last dose, or until resolution, whichever came first, or up to approximately 10 months.

,,,,,,,
InterventionPercentage of participants (Number)
TEAEsTreatment-related TEAEsSevere TEAEsSerious TEAEsTEAEs leading to study treatment withdrawalTEAEs leading to study treatment dose decreaseTEAEs leading to study treatment interruption
0.005% E6201 Gel0000000
0.01% E6201 Gel0000000
0.03% E6201 Gel4400100
0.05% E6201 Gel5500000
0.1% E6201 Gel6600000
0.2% E6201 Gel6600000
Daivonex (Calcipotriene Cream)3300100
E6201 Vehicle1100100

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Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation

Clinical (global) assessment of the test fields was performed using a 5-point score: -1 = worsened, 0 = unchanged (no effect), 1 = slight improvement, 2 = clear improvement but not completely healed, and 3 = completely healed. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Clinically apparent differences in erythema and infiltration contributed to the global assessment. Baseline was defined as Visit 2 (Day 0). (NCT01268527)
Timeframe: Day 12/Discontinuation (Visit 14/End of Treatment)

,,,,,,,
InterventionPercentage of participants (Number)
WorsenedUnchanged (no effect)Slight improvementClear improvement but not completely healedCompletely healed
0.005% E6201 Gel020.066.713.30
0.01% E6201 Gel0033.366.70
0.03% E6201 Gel06.746.746.70
0.05% E6201 Gel0013.386.70
0.1% E6201 Gel0083.316.70
0.2% E6201 Gel0083.3016.7
Daivonex (Calcipotriene Cream)06.756.733.33.3
E6201 Vehicle090.010.000

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Clinical (Global) Assessment of Efficacy on Day 8

Clinical (global) assessment of the test fields was performed using a 5-point score: -1 = worsened, 0 = unchanged (no effect), 1 = slight improvement, 2 = clear improvement but not completely healed, and 3 = completely healed. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Clinically apparent differences in erythema and infiltration contributed to the global assessment. Baseline was defined as Visit 2 (Day 0). (NCT01268527)
Timeframe: Day 8 (Visit 10)

,,,,,,,
InterventionPercentage of participants (Number)
WorsenedUnchanged (no effect)Slight improvementClear improvement but not completely healedCompletely healed
0.005% E6201 Gel033.366.700
0.01% E6201 Gel06.753.340.00
0.03% E6201 Gel6.76.760.026.70
0.05% E6201 Gel0013.386.70
0.1% E6201 Gel016.783.300
0.2% E6201 Gel0010000
Daivonex (Calcipotriene Cream)3.320.046.730.00
E6201 Vehicle3.390.06.700

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Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate

The AUC was based on the baseline-corrected thickness of the psoriatic infiltrate (20 megahertz (MHz) Sonographic measurement) at specified days for each treatment field calculated by applying the linear trapezoidal rule. Sonographic measurements were performed using a 20 MHz high-frequency sonograph. Serial A-scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore, exact measurement of skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent band below the entrance echo. The thickness of the echo lucent psoriatic band was determined. The thickness was measured in micrometers (um) and was denoted as T. (NCT01268527)
Timeframe: Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment)

Interventionum.day (Least Squares Mean)
Daivonex (Calcipotriene Cream)-1449.2
E6201 Vehicle17.0
0.005% E6201 Gel-694.4
0.01% E6201 Gel-1102.8
0.03% E6201 Gel-763.1
0.05% E6201 Gel-1758.2
0.1% E6201 Gel-904.4
0.2% E6201 Gel-920.8

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Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation)

Psoriatic infiltrate thickness was determined by 20 MHz Sonographic measurements using a 20 MHz high-frequency sonograph. Serial-A scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore exact measurement of the skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent back below the entrance echo. The thickness of the echo lucent psoriatic band was determined. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Baseline was defined as Visit 2 (Day 0). Least Squares Means (LSM) and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. (NCT01268527)
Timeframe: Day 12/Discontinuation (Visit 14/End of Treatment)

Interventionum (Least Squares Mean)
Daivonex (Calcipotriene Cream)-205.3
E6201 Vehicle7.1
0.005% E6201 Gel-94.4
0.01% E6201 Gel-175.3
0.03% E6201 Gel-162.4
0.05% E6201 Gel-239.5
0.1% E6201 Gel-125.2
0.2% E6201 Gel-137.9

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Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8

Psoriatic infiltrate thickness was determined by 20 MHz Sonographic measurements using a 20 MHz high-frequency sonograph. Serial-A scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore exact measurement of the skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent back below the entrance echo. The thickness of the echo lucent psoriatic band was determined. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Baseline was defined as Visit 2 (Day 0). LSM and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. (NCT01268527)
Timeframe: Day 8 (Visit 10)

Interventionum (Least Squares Mean)
Daivonex (Calcipotriene Cream)-151.7
E6201 Vehicle17.3
0.005% E6201 Gel-63.4
0.01% E6201 Gel-110.7
0.03% E6201 Gel-92.9
0.05% E6201 Gel-190.3
0.1% E6201 Gel-108.0
0.2% E6201 Gel-102.7

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Change in mPASI From Baseline to Week 1

The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8 (NCT01422434)
Timeframe: Baseline to Week 1

Interventionpercentage of change (Mean)
Dovonex® Ointment-23.7
LEO 90105 Ointment-39.1
Rinderon® - DP Ointment-29.5

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Physician's Global Assessment of Psoriasis

"Subjects with 'clear' or 'almost clear' disease by physician's global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.~The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit." (NCT01422434)
Timeframe: Week 4

Interventionparticipants (Number)
Dovonex® Ointment52
LEO 90105 Ointment89
Rinderon® - DP Ointment43

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Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)

"The primary response criterion was the percentage change in m-PASI from baseline to Week 4.~The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:~Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8." (NCT01422434)
Timeframe: Baseline to Week 4

Interventionpercentage of change (Mean)
Dovonex® Ointment-50.5
LEO 90105 Ointment-64.3
Rinderon® - DP Ointment-53.6

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Change From Baseline in Target Lesion Assessment

"Percentage change in composite severity score of the target lesion from baseline to Week 4.~At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.~At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.~The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated." (NCT01422434)
Timeframe: Baseline to Week 4

Interventionpercentage of change (Mean)
Dovonex® Ointment-57.1
LEO 90105 Ointment-70.5
Rinderon® - DP Ointment-58.6

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Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail

"The target nail will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using modified target NAPSI score (mtNAPSI, 0-96).~mtNAPSI evaluation: a target nail is divided into 4 quadrants and for each quadrant the nail parameters (oil drop, onycholysis, hyperkeratosis, hemorrhages, pitting, leukonychia, red spots on the lunula, and crumbling) are assessed separately: 0 = no sign, 1 = mild, 2 = moderate, and 3 = severe; the range of mtNAPSI is between 0 and 96, with higher score indicating more severe symptoms." (NCT01445886)
Timeframe: Baseline and 24 weeks

,
Interventionunits on a scale (Mean)
baselineweek 24
Calcipotriol Solution16.99.5
Indigo Naturalis Oil Extract17.75.9

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Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks

"The nails will be assessed by two dermatologists at baseline and after treatment 4, 8, 12, 16, 20, 24 weeks using single-handed Nail Psoriasis Severity Index (shNAPSI) score. shNAPSI evaluation: Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) , the total of which is the score for that nail (0-8); the range of shNAPSI of one hand is between 0 and 40, with higher score indicating more severe symptoms. Nail bed psoriasis: presence of any of the nail bed features (onycholysis, hemorrhages, hyperkeratosis, oil drop (salmon patch dyschroma): 0 for none, 1 for 1 quadrant only, 2 for 2 quadrants, 3 for 3 quadrants, and 4 for 4 quadrants. Nail matrix psoriasis: presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling): 0 for none, 1 if present in 1 quadrant of the nail, 2 if present in 2 quadrants of the nail, 3 if present in 3 quadrants of the nail, and 4 if present in 4 quadrants of the nail." (NCT01445886)
Timeframe: Baseline and 24 weeks

,
Interventionunits on a scale (Mean)
baselineweek 24
Calcipotriol Solution27.420.4
Indigo Naturalis Oil Extract27.214.4

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Physician's and Subject's Global Assessment

"The Physician's and Subject's Global Assessment (PGA and SGA) will be assessed by two dermatologists and participant himself/herself respectively after treatment 24 weeks.~A 6-point scale was used for both SGA and PGA: 0 = worse, 1 = 0-24% clearing with little or no change, 2 = 25-49% clearing with slight improvement, 3 = 50-74% clearing with moderate improvement, 4 = 75-99% clearing with striking improvement, 5 = cleared. A score between 3 and 5 was considered to be a positive response and a score between 0 and 2 a poor response." (NCT01445886)
Timeframe: Week 24

,
Interventionunits on a scale (Mean)
PGA 1PGA 2SGA
Calcipotriol Solution2.52.32.6
Indigo Naturalis Oil Extract3.73.43.9

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Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.

Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation. (NCT01536886)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 9010077
Calcipotriol Plus BDP Ointment58
LEO 90100 Vehicle3
Ointment Vehicle4

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Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.

Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation. (NCT01536938)
Timeframe: 4 weeks

Interventionparticipants (Number)
LEO 9010045
Betamethasone Dipropionate31
Calcipotriol Aerosol Foam15

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Change in Lesion Thickness From Baseline to Day 22

Change in total skin thickness measured by ultrasound from baseline to end of treatment (NCT01580488)
Timeframe: Baseline to Day 22

Interventionmillimeters (Mean)
B LEO 35299 20 mg/g-0.31
C LEO 35299 20 mg/g-0.18
E LEO 35299 10 mg/g-0.22
F LEO 35299 10 mg/g-0.24
Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment-0.36
Daivonex® Ointment-0.38

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Change in Infiltration From Baseline to Day 22

Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01580488)
Timeframe: Baseline to Day 22

Interventionunits on a scale (Mean)
B LEO 35299 20 mg/g-0.87
C LEO 35299 20 mg/g-0.59
E LEO 35299 10 mg/g-0.46
F LEO 35299 10 mg/g-0.46
Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment-1.48
Daivonex® Ointment-1.11

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Change in Erythema From Baseline to Day 22

Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01580488)
Timeframe: Baseline to Day 22

Interventionunits on a scale (Mean)
B LEO 35299 20 mg/g-0.91
C LEO 35299 20 mg/g-0.67
E LEO 35299 10 mg/g-0.54
F LEO 35299 10 mg/g-0.70
Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment-1.09
Daivonex® Ointment-1.07

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Change in the Total Clinical Score From Baseline to Day 22

Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe) (NCT01580488)
Timeframe: Baseline to Day 22

Interventionunits on a scale (Mean)
B LEO 35299 20 mg/g-2.8
C LEO 35299 20 mg/g-1.9
E LEO 35299 10 mg/g-1.5
F LEO 35299 10 mg/g-1.8
Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment-4.0
Daivonex® Ointment-3.3

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Change in Scaling From Baseline to Day 22

Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent). (NCT01580488)
Timeframe: Baseline to Day 22

Interventionunits on a scale (Mean)
B LEO 35299 20 mg/g-1.09
C LEO 35299 20 mg/g-0.74
E LEO 35299 10 mg/g-0.61
F LEO 35299 10 mg/g-0.67
Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment-1.52
Daivonex® Ointment-1.30

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Change in Skin Thickness From Baseline to Day 22

Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment (NCT01580488)
Timeframe: Baseline to Day 22

Interventionmillimeters (Mean)
B LEO 35299 20 mg/g-0.40
C LEO 35299 20 mg/g-0.29
E LEO 35299 10 mg/g-0.24
F LEO 35299 10 mg/g-0.40
Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment-0.57
Daivonex® Ointment-0.49

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Lesion Counts (Total, Inflammatory and Non-inflammatory)

Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. (NCT01694433)
Timeframe: Weeks 2, 4, 8 & 12

,
InterventionLesions (Mean)
Inflammatory lesions at Week 2Inflammatory lesions at Week 4Inflammatory lesions at Week 8Inflammatory lesions at Week 12Non-inflammatory lesions at Week 2Non-inflammatory lesions at Week 4Non-inflammatory lesions at Week 8Non-inflammatory lesions at Week 12Total lesions at Week 2Total lesions at Week 4Total lesions at Week 8Total lesions at Week 12
Calcipotriene Cream18.415.812.110.530.935.522.119.651.051.434.230.1
Placebo13.49.910.27.033.134.424.320.246.544.334.5527.24

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Acne Severity as Assessed With the Investigator's Global Assessment (IGA)

Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe) (NCT01694433)
Timeframe: Weeks 2, 4, 8 & 12

,
Interventionscore on a scale (Mean)
IGA at Week 2IGA at Week 4IGA at Week 8IGA at Week 12
Calcipotriene Cream2.772.832.212.23
Placebo2.92.592.482.31

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Subjective Subject Preference Survey for the First Treatment Session

Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105. (NCT01707043)
Timeframe: 3 days

Interventionunits on a scale (Mean)
Taclonex Scalp Suspension First Then Taclonex Ointment81.1
Taclonex Ointment First, Then Taclonex Scalp Suspension77.6

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Subjective Subject Preference Survey for the Second Treatment Session

Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105. (NCT01707043)
Timeframe: 3 days

Interventionunits on a scale (Mean)
Taclonex Scalp Suspension First Then Taclonex Ointment78.9
Taclonex Ointment First, Then Taclonex Scalp Suspension69.4

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Physician Global Assessement

"Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear~= almost clear~= mild~= moderate~= severe" (NCT01745133)
Timeframe: 10 weeks

Interventionpercentage of patients (Number)
Vehicle 68%68
Calcipotriene 80%80
Calcipotriene + Clobetasol Propionate 79%79

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Treatment Success According to the PGA

"To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.~Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA).~'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline." (NCT02132936)
Timeframe: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel

Interventionpercentage of subjects (Number)
LEO 9010038.3
Calcipotriol BDP Gel22.5

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Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.

Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel. (NCT02132936)
Timeframe: Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel

Interventionpercentage of subjects (Number)
LEO 9010052.1
Calcipotriol BDP Gel34.6

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Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).

Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). (NCT02132936)
Timeframe: Baseline to Week 4; Baseline to Week 8

Interventionunits on a scale (Mean)
LEO 90100-30.5
Calcipotriol BDP Gel-28.5

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Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).

Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). (NCT02132936)
Timeframe: Baseline to Week 4

Interventionunits on a scale (Mean)
LEO 90100-30.5
Aerosol Foam Vehicle-15.9

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Time to 'Treatment Success' According to PGA.

"Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.~'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline." (NCT02132936)
Timeframe: From Baseline to Week 12

Interventionweeks (Median)
LEO 901006
Calcipotriol BDP GelNA

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Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12

(NCT02193815)
Timeframe: Day 1 (Baseline), Day 12

,
Interventionmicrometers (Mean)
BaselineChange at Day 12
Tofacitinib 2% Ointment364.1-117.8
Tofacitinib Vehicle357.30.1

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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs

An AE was any untoward medical occurrence in a participant who received study drug. An 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported. (NCT02193815)
Timeframe: Baseline up to 28 days after last study drug administration (Day 21)

,,,,,
Interventionparticipants (Number)
Specified Skin AEsSpecified Skin SAEs
Daivonex Ointment20
Daivonex Solution00
PF-06263276 4% Solution00
PF-06263276 Vehicle00
Tofacitinib 2% Ointment00
Tofacitinib Vehicle00

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Number of Participants With Potentially Clinically Significant Vital Signs Findings

Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg. (NCT02193815)
Timeframe: Baseline up to Day 12

Interventionparticipants (Number)
SBP <90 mmHgDBP <50 mmHgPulse Rate <40 or >120 bpmMaximum Increase from Baseline in SBP >=30 mmHgMaximum Increase from Baseline in DBP >=20 mmHg
All Participants00000

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Global Clinical Assessment at Day 1, 8 and 12

"Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged)." (NCT02193815)
Timeframe: Day 1, Day 8, Day 12

,,,,,
Interventionparticipants (Number)
Day 1: Score -1Day 1: Score 0Day 1: Score 1Day 1: Score 2Day 1: Score 3Day 8: Score -1Day 8: Score 0Day 8: Score 1Day 8: Score 2Day 8: Score 3Day 12: Score -1Day 12: Score 0Day 12: Score 1Day 12: Score 2Day 12: Score 3
Daivonex Ointment0150000168012480
Daivonex Solution0150001194011670
PF-06263276 4% Solution015000013200013200
PF-06263276 Vehicle015000015000015000
Tofacitinib 2% Ointment0150000483004830
Tofacitinib Vehicle015000014010011310

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Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB

The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported. (NCT02193815)
Timeframe: Day 1 (baseline) up to Day 12

Interventionmicrometers*day (Mean)
PF-06263276 4% Solution4082.60
PF-06263276 Vehicle4161.40
Tofacitinib 2% Ointment3271.93
Tofacitinib Vehicle4013.07
Daivonex Solution3322.40
Daivonex Ointment3165.47

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Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12

(NCT02193815)
Timeframe: Day 1 (Baseline), Day 12

Interventionmicrometers (Mean)
PF-06263276 4% Solution17.7
Daivonex Solution-135.5

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Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential). (NCT02193815)
Timeframe: Baseline up to Day 12

Interventionparticipants (Number)
All Participants6

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Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12

Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin. (NCT02193815)
Timeframe: Day 1 (Baseline), Day 12

,
Interventionmicrometers (Mean)
BaselineChange at Day 12
PF-06263276 4% Solution358.917.7
PF-06263276 Vehicle353.132.9

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Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8

(NCT02193815)
Timeframe: Day 1 (Baseline), Day 8

,,,,,
Interventionmicrometers (Mean)
BaselineChange at Day 8
Daivonex Ointment364.1-104.7
Daivonex Solution376.1-98.8
PF-06263276 4% Solution358.918.0
PF-06263276 Vehicle353.138.5
Tofacitinib 2% Ointment364.1-90.5
Tofacitinib Vehicle357.315.1

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Dermatology Life Quality Index (DLQI)

"Change from baseline to week 4~Description of Dermatology Life Quality Index (DLQI): A score from 0-30 [0, patients' quality of life not affected; 30, patients' quality of life severely affected by the skin disease]. The DLQI-scale is a summary of 10 questions on subscales, where patients' report how severely their quality of life has been affected for the last week (patient reported outcome measurements (PROM), each subscale have a score from 0 (not affected by skin disease) to 3 (severely affected by skin disease).~The minimum score is 0 and the highest score is 30, a high score means worse outcome." (NCT02858713)
Timeframe: Baseline, week 4, 8 and 26

,
Interventionunits on a scale (Mean)
Change from baseline to week 4Change from baseline to week 8Change from baseline to week 26
App as Intervention + Enstilar©4.124.594.23
Conventional Instructions + Enstilar©4.545.175.00

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Lattice-System Physician's Global Assessment (LS-PGA)

"Change from baseline to week 4, 8 and 26~Lattice System Physican's Gloabal Assessment (LS-PGA) is a measure from 0-8 (0, patients skin clear; 8, patients' skin severely affected by psoriasis). The scale is a summary of three subscales: 1). thickness of psoriasis, 2). extent of scaling and 3). body surface ares (BSA) affected. The minimum score is 0 and the maximum score is 8, a high score represents a worse outcome." (NCT02858713)
Timeframe: Week 4, 8 and 26

,
Interventionunits on a scale (Mean)
Change from baseline to week 4Change from baseline to week 8Change from baseline to week 26
App + Enstilar©1.862.251.98
Conventional Instructions + Enstilar©1.462.161.80

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Percentage of Adherent Participants

Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent (NCT02858713)
Timeframe: Week 4

Interventionpercentage of participants (Number)
App as Intervention + Enstilar©65
Conventional Instructions + Enstilar©38

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Change From Baseline in Fluorescence Intensity of PPIX

"Measurement of PPIX fluorescence on both sides of the scalp before and immediately after LED illumination PpIX fluorescence was measured in three different spot areas on the scalp before and immediately after PDT on each side.~The measurements were taken noninvasively in the areas where PpIX fluorescence was more intense, with a handheld fluorescence photometer (USB 2000+ spectroscopy device; Ocean Optics, Dunedin, FL, U.S.A.). The photometer illuminates a circular skin area with a diameter of 1 cm with blue light (400-420 nm), matching the Soret band of PpIX at 405-420 nm. By measuring excitation wavelengths at 600- 700 nm, the corresponding red PpIX fluorescence intensity at 633 nm is detected. Measurements were taken in arbitrary units. The mean PpIX fluorescence value for each side was calculated before and after the treatment." (NCT02878382)
Timeframe: Baseline and 10 minutes after illumination

Interventionarbitrary units (Mean)
Calcipotriol Assisted MAL-PDT3422.85
Conventional MAL-PDT2688.35

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Changes From Baseline in Actinic Keratosis - Lesion Base Count.

"To compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp.~The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention.~Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side." (NCT02878382)
Timeframe: Change from baseline, 90 days, 180 days and 12 months after the PDT

,
Interventionlesions (Mean)
3 months outcome6 months outcome12 months outcome
Calcipotriol Assisted MAL-PDT1.151.151.35
Conventional MAL-PDT2.652.603.20

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Percentage of Actinic Keratosis (AK) Lesions Cleared

"AK clearance after PDT and comparison between the sides The values in the data table represent the percentage of AK clearance on each side at 3, 6 and 12 months post intervention.~At baseline: 290 on the CAL-PDT side and 284 on the conventional side." (NCT02878382)
Timeframe: Change from baseline, 90 days, 6 months and 12 months after PDT

,
Interventionpercentage of lesions cleared (Number)
3 months outcome6 months outcome12 months outcome
Calcipotriol Assisted MAL-PDT92.192.190.7
Conventional MAL-PDT8281.777.5

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Pain Scores Immediately Post Illumination

"Measurement of pain during LED illumination and comparison between the sides with a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain.~At baseline, before the illumination, there is an absence of pain, which means Score 0 (zero) for all participants before the procedure.~Pain is reffered during and after the illumination and measured with the VAS scale, reported by each patient." (NCT02878382)
Timeframe: immediately after intervention

Interventionunits on a scale (Mean)
Calcipotriol Assisted MAL-PDT5.4
Conventional MAL-PDT4.0

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Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16

The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe (NCT03441789)
Timeframe: 4 weeks, 12 weeks, 16 weeks

InterventionParticipants (Count of Participants)
week 472517757week 472517758week 1272517758week 1272517757week 1672517758week 1672517757
severeclearalmost clearmildmoderate
Otezla Plus Enstilar Foam5
Otezla Plus Enstilar Foam7
Otezla Plus Vehicle Foam0
Otezla Plus Vehicle Foam3
Otezla Plus Vehicle Foam4
Otezla Plus Enstilar Foam6
Otezla Plus Vehicle Foam7
Otezla Plus Enstilar Foam1
Otezla Plus Vehicle Foam1
Otezla Plus Enstilar Foam8
Otezla Plus Enstilar Foam4
Otezla Plus Enstilar Foam0
Otezla Plus Vehicle Foam9

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Percent of Subjects With PASI 75 at Week 4 and Week 12

Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) (NCT03441789)
Timeframe: 4 weeks, 12 weeks

,
InterventionParticipants (Count of Participants)
week 4week 12
Otezla Plus Enstilar Foam74
Otezla Plus Vehicle Foam12

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Percent of Subjects With PASI 90 and 100 at Week 16

Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) (NCT03441789)
Timeframe: 16 weeks

,
InterventionParticipants (Count of Participants)
PASI 90PASI 100
Otezla Plus Enstilar Foam41
Otezla Plus Vehicle Foam20

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Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16

The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life. (NCT03441789)
Timeframe: 4 weeks, 12, weeks, 16 weeks

,
Interventionscore on a scale (Mean)
week 4week 12week 16
Otezla Plus Enstilar Foam253
Otezla Plus Vehicle Foam556

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Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16

PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs) (NCT03441789)
Timeframe: 16 weeks

InterventionParticipants (Count of Participants)
Otezla Plus Enstilar Foam7
Otezla Plus Vehicle Foam2

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Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16

The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome. (NCT03441789)
Timeframe: 4 weeks, 12 weeks, 16 weeks

,
Interventionscale unit (Mean)
week 4week 12week 16
Otezla Plus Enstilar Foam243
Otezla Plus Vehicle Foam544

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Number of Participants With Treatment-emergent Adverse Events (AEs)

Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
PF-06763809+Vehicle+Calcipotriene+Betamethasone6

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Area Under the Curve of the Psoriatic Skin Infiltrate Thickness

Baseline was defined to be the measurement on Day 1. To evaluate the Area Under the Curve (AUC) of psoriatic skin infiltrate thickness/EPB for PF 06763809 compared to vehicle by mixed model analysis. The AUC of the psoriatic skin infiltrate thickness/EPB from Day 1 to Day 19 was determined using the linear trapezoidal rule. The log AUC was performed by the natural logarithm of the AUC of the psoriatic skin infiltrate thickness/EPB. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Day 1 to Day 19

Interventionnanograms*hour per milliliter (ng*h/mL) (Geometric Mean)
A: PF-06763809 2.3% Solution6191.52
B: PF-06763809 0.8% Solution5996.26
C: PF-06763809 0.23% Solution6921.58
D: PF-06763809 Vehicle6204.82

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Change From Baseline in Psoriatic Skin Infiltrate Thickness

Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Baseline, Days 7, 13 and 19

,,,
Interventionmicrometer (μm) (Geometric Mean)
Day 7Day 13Day 19
A: PF-06763809 2.3% Solution0.890.740.71
B: PF-06763809 0.8% Solution0.920.760.70
C: PF-06763809 0.23% Solution0.970.870.80
D: PF-06763809 Vehicle0.930.800.70

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Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria

Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
DBP Value <50 mmHgDBP Chg >= 20 mmHg increaseDBP Chg >= 20 mmHg decreasePulse Rate Value <40 beats per minute (bpm)Pulse Rate Value >120 bpmSBP Value <90 mmHgSBP Chg >= 30 mmHg increaseSBP Chg >= 30 mmHg decrease
PF-06763809+Vehicle+Calcipotriene+Betamethasone00000000

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Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
Hemoglobin (HGB) (g/dL) <0.8xLLNHematocrit (%) <0.8xLLNErythrocytes (10^6/mm^3) <0.8xLLNEry. Mean Corpuscular Volume (μm^3) <0.9xLLNEry. Mean Corpuscular Volume (μm^3) >1.1xULNEry. Mean Corpuscular HGB (pg/cell) <0.9xLLNEry. Mean Corpuscular HGB (pg/cell) >1.1xULNEry. Mean Corpuscular HGB Conc. (g/dL) <0.9xLLNEry. Mean Corpuscular HGB Conc. (g/dL) >1.1xULNPlatelets (10^3/mm^3) <0.5xLLNPlatelets (10^3/mm^3) >1.75xULNLeukocytes (10^3/mm^3) <0.6xLLNLeukocytes (10^3/mm^3) >1.5xULNLymphocytes (10^3/mm^3) <0.8xLLNLymphocytes (10^3/mm^3) >1.2xULNNeutrophils (10^3/mm^3) <0.8xLLNNeutrophils (10^3/mm^3) >1.2xULNBasophils (10^3/mm^3) >1.2xULNEosinophils (10^3/mm^3) >1.2xULNMonocytes (10^3/mm^3) >1.2xULNBilirubin (mg/dL) >1.5xULNAspartate Aminotransferase (U/L) >3.0xULNAlanine Aminotransferase (U/L) >3.0xULNAlkaline Phosphatase (U/L) >3.0xULNProtein (g/dL) <0.8xLLNProtein (g/dL) >1.2xULNAlbumin (g/dL) <0.8x LLNAlbumin (g/dL) >1.2xULNUrea Nitrogen (mg/dL) >1.3xULNUrea (mmol/L) >1.3xULNCreatinine (mg/dL) >1.3xULNUrate (mg/dL) >1.2xULNSodium (mEq/L) <0.95xLLNSodium (mEq/L) >1.05xULNPotassium (mEq/L) <0.9x LLNPotassium (mEq/L) >1.1xULNChloride (mEq/L) <0.9xLLNChloride (mEq/L) >1.1xULNCalcium (mg/dL) <0.9x LLNCalcium (mg/dL) >1.1xULNBicarbonate (mEq/L) <0.9x LLNBicarbonate (mEq/L) >1.1xULNGlucose (mg/dL) <0.6xLLNGlucose (mg/dL) >1.5xULNpH (Scalar) <4.5pH (Scalar) >8URINE Glucose (Scalar) >=1Ketones (Scalar) >=1URINE Protein (Scalar) >=1URINE Hemoglobin (Scalar) >=1Urobilinogen (Scalar) >=1URINE Bilirubin (Scalar) >=1Nitrite (Scalar) >=1Leukocyte Esterase (Scalar) >=1
PF-06763809+Vehicle+Calcipotriene+Betamethasone000010010000020000010000000000000000000000000000000000

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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value>=300 milliseconds [msec], %Change [Chg]>=25/50%); 2) QRS interval (Value>=140 msec, >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec. The corrected QT interval by Fredericia=QTcF Interval. (NCT03469336)
Timeframe: Day 1 to Day 49

InterventionParticipants (Count of Participants)
Value>=300 msec (PR Interval)%Change (Chg)>=25/50% (PR Interval)Value>=140 msec (QRS Interval)%Chg>=50% (QRS Interval)Value>=500 msec (QT Interval)450<=Value<480 msec (QTc Interval)480<=Value<500 msec (QTc Interval)Value>=500 msec (QTc Interval)30<=Chg<60 msec (QTc Interval)Chg>=60 msec (QTc Interval)450<=Value<480 msec (QTcF Interval)480<=Value<500 msec (QTcF Interval)Value>=500 msec (QTcF Interval)30<=Chg<60 msec (QTcF Interval)Chg>=60 msec (QTcF Interval)
PF-06763809+Vehicle+Calcipotriene+Betamethasone000002002100000

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Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.

The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Baseline, Days 7, 13 and 19

,,,
Interventionμm (Geometric Mean)
Day 7Day 13Day 19
A: PF-06763809 2.3% Solution0.890.740.71
B: PF-06763809 0.8% Solution0.920.760.70
C: PF-06763809 0.23% Solution0.970.870.80
E: Calcipotriene/Calcipotriol Solution0.770.860.90

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Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.

The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB both within and following 18 days of treatment. Baseline was defined to be the measurement on Day 1. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories. (NCT03469336)
Timeframe: Baseline, Days 7, 13 and 19

,,,
Interventionμm (Geometric Mean)
Day 7Day 13Day 19
A: PF-06763809 2.3% Solution0.890.740.71
B: PF-06763809 0.8% Solution0.920.760.70
C: PF-06763809 0.23% Solution0.970.870.80
F: Betamethasone Solution.0.430.030.01

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Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema

A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
0 None8 Extremely Red6 Very Red4 Red2 Pink1 Slightly Pink
Enstilar Foam5
Enstilar Foam13
Enstilar Foam2
Enstilar Foam0
Enstilar Foam4
Enstilar Foam14
Enstilar Foam1
Enstilar Foam7
Enstilar Foam8

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Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration

A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
1 Very Slight0 None6 Marked3 Mild2 Slight4 Moderate
Enstilar Foam5
Enstilar Foam13
Enstilar Foam2
Enstilar Foam3
Enstilar Foam1
Enstilar Foam9
Enstilar Foam6
Enstilar Foam0
Enstilar Foam8
Enstilar Foam11

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Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4

Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%) (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

Interventionpercentage of body covered by psoriasis (Mean)
BaselineWeek 2Week 4
Enstilar Foam9.89.26.9

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Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling

A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion) (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
8 Very Severe4 Moderate6 Severe2 Mild0 None
Enstilar Foam7
Enstilar Foam12
Enstilar Foam0
Enstilar Foam1
Enstilar Foam10
Enstilar Foam9
Enstilar Foam4
Enstilar Foam15

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Change in Lesion Size From Baseline to Week 2 and Week 4

Size of target lesion recorded as height in cm x length in cm (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

Interventioncm^2 (Mean)
BaselineWeek 2Week 4
Enstilar Foam191610

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Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4

Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate (NCT03848871)
Timeframe: screening/baseline, week 2, week 4

InterventionParticipants (Count of Participants)
Baseline72169599Week 272169599Week 472169599
Almost ClearClearModerateMild
Enstilar Foam20
Enstilar Foam0
Enstilar Foam1
Enstilar Foam13
Enstilar Foam4
Enstilar Foam9
Enstilar Foam6

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