oxybutynin and Dermatitis, Contact studies

oxybutynin: RN given refers to parent cpd
oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.

Dermatitis, Contact: A type of acute or chronic skin reaction in which sensitivity is manifested by reactivity to materials or substances coming in contact with the skin. It may involve allergic or non-allergic mechanisms.

Research Excerpts

Excerpt	Relevance	Reference
" The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46."	6.82	The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study. ( Hoshino, Y; Matsumoto, H; Matsushita, I; Otsuka, N; Yataba, I, 2016)
" The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46."	2.82	The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study. ( Hoshino, Y; Matsumoto, H; Matsushita, I; Otsuka, N; Yataba, I, 2016)
" The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4."	2.71	Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. ( Davila, GW; Dmochowski, RR; Gittelman, MC; Sand, PK; Sanders, SW; Zinner, NR, 2003)
" Rivastigmine, a cholinesterase inhibitor, is commonly used as a treatment for dementia due to its ability to moderate cholinergic neurotransmission; however, treatment with oral rivastigmine can lead to gastrointestinal adverse effects such as nausea and vomiting."	2.47	Transdermal rivastigmine: management of cutaneous adverse events and review of the literature. ( Adam, DN; Greenspoon, J; Herrmann, N, 2011)
"Safety and tolerability assessment included the monitoring and recording of adverse events and withdrawals at any time during the study."	1.38	Safety and tolerability of rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions. ( Pregelj, P, 2012)

Research

Studies (9)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Cycle Control

Timeframe	Studies, this research(%)	All Research%
pre-1990	2 (22.22)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (11.11)	29.6817
2010's	6 (66.67)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Solinski, HJ	1
Dranchak, P	1
Oliphant, E	1
Gu, X	1
Earnest, TW	1
Braisted, J	1
Inglese, J	1
Hoon, MA	1
Dmochowski, RR	1
Sand, PK	1
Zinner, NR	1
Gittelman, MC	1
Davila, GW	1
Sanders, SW	1
Khoo, ABS	1
Haque-Hussain, S	1
Kaunitz, AM	1
Portman, D	1
Westhoff, CL	1
Mishell, DR	1
Archer, DF	1
Foegh, M	1
Yataba, I	1
Otsuka, N	1
Matsushita, I	1
Matsumoto, H	1
Hoshino, Y	1
Greenspoon, J	1
Herrmann, N	1
Adam, DN	1
Pregelj, P	1
KLAUDER, JV	1
MORRIS, GE	1
BIRMINGHAM, DJ	1
FLEGEL, H	1
FIEDLER, H	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.[NCT01181479]	Phase 3	1,504 participants (Actual)	Interventional	2010-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS. (NCT01181479)
Timeframe: 6 months

Patch Adhesion by Investigator Evaluation at Each Visit

Intervention	percentage of cycles with BTB/BTS (Number)
AG200-15 for Cycle 1-6	23.9
Lessina	21.2

"Evaluation of patch adhesion was determined using the following scores:~0: >= 90% adhered (no lift)~>= 75% adhered but < 90% (some edges showing lift)~>= 50% adhered but < 75% (half of system lifts off)~< 50% (> half of system lifts off, but undetached)~patch completely detached" (NCT01181479)
Timeframe: 1 year

Pregnancy

Intervention	Score on a scale (Mean)
All Subjects Who Applied AG200-15	0.29

Pregnancy outcomes was determine by measuring Pearl index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use. (NCT01181479)
Timeframe: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year

Self-reported Irritation at Application Site

Intervention	Pearl Index (Number)
AG200-15 for Cycle 7-13	5.41
Lessina	6.67
AG200-15 for Cycle 1-13	6.43

"Evaluation of irritation at application site was determined using the following scores:~0: None~Mild~Moderate~Severe" (NCT01181479)
Timeframe: 1 year

Self-reported Itching at Patch Application Site

Intervention	Score on scale (Mean)
All Subjects Who Applied AG200-15	1.35

"Evaluation of itching at patch application site was determined using the following scores:~0: None~Mild~Moderate~Severe" (NCT01181479)
Timeframe: 1 year

Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)

Intervention	Score on a scale (Mean)
All Subjects Who Applied AG200-15	1.48

Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13. (NCT01181479)
Timeframe: Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months

Intervention	pg/ml (Mean)
	EE for cycle 2	EE cycle 6	EE cycle 13	LNG cycle 2	LNG cycle 6	LNG cycle 13
AG200-15 for Cycle 1-13	30.5	36.7	31	1201	1753	1590
AG200-15 for Cycles 7-13	NA	NA	33.4	NA	NA	1750
Lessina Cycles 1-6	35.4	40.1	NA	2386	2611	NA

Article	Year
Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Urology, 2003, Volume: 62, Issue:2 Topics: Administration, Cutaneous; Administration, Oral; Benzhydryl Compounds; Cresols; Dermatitis, Contact;	2003
New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception, 2015, Volume: 91, Issue:3 Topics: Adhesiveness; Adolescent; Adult; Contraceptives, Oral, Combined; Dermatitis, Contact; Drug Combinati	2015
The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study. Clinical drug investigation, 2016, Volume: 36, Issue:8 Topics: Administration, Topical; Aged; Anti-Inflammatory Agents, Non-Steroidal; Dermatitis, Contact; Female;	2016

Article	Year
Inhibition of natriuretic peptide receptor 1 reduces itch in mice. Science translational medicine, 2019, 07-10, Volume: 11, Issue:500 Topics: Animals; Behavior, Animal; Cell-Free System; Dermatitis, Contact; Disease Models, Animal; Ganglia, S	2019
A differential diagnosis for annular lesions: contact dermatitis to transdermal rivastigmine patches. BMJ case reports, 2018, Aug-03, Volume: 2018 Topics: Aged; Dermatitis, Contact; Diagnosis, Differential; Humans; Male; Memory Disorders; Neuroprotective	2018
Safety and tolerability of rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions. Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society, 2012, Volume: 12, Issue:3 Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Alzheimer Disease; Cholinesterase Inhibit	2012
Dermatology in industrial medicine. II. Of what value is pre-employment patch test? Industrial medicine & surgery, 1957, Volume: 26, Issue:4 Topics: Dermatitis; Dermatitis, Contact; Dermatology; Employment; Humans; Occupational Health; Occupational	1957
[Studies on the diagnostic value of the epicutaneous patch test]. Zeitschrift fur Haut- und Geschlechtskrankheiten, 1961, Mar-01, Volume: 30 Topics: Dermatitis, Contact; Humans; Occupational Diseases; Patch Tests; Skin Tests; Transdermal Patch	1961

oxybutynin and Dermatitis, Contact