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Adapalene

Generic Name
Adapalene
Brand Names
Cabtreo, Differin, Epiduo, Panoxyl, Tactupump
Drug Type
Small Molecule
Chemical Formula
C28H28O3
CAS Number
106685-40-9
Unique Ingredient Identifier
1L4806J2QF
Background

Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne.

Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.

Indication

Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over. It is also indicated for acne vulgaris in combination with benzoyl peroxide and in a triple combination therapy with benzoyl peroxide and clindamycin.

Associated Conditions
Acne Vulgaris

A Treatment for Severe Inflammatory Acne Subjects

First Posted Date
2016-09-13
Last Posted Date
2022-12-09
Lead Sponsor
Galderma R&D
Target Recruit Count
186
Registration Number
NCT02899000
Locations
🇺🇸

Galderma Laboratories, LP, Fort Worth, Texas, United States

Tazarotene Plus Clindamycin vs. Adapalene Plus Clindamycin in the Treatment of Facial Acne Vulgaris

First Posted Date
2016-03-29
Last Posted Date
2017-01-18
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Target Recruit Count
60
Registration Number
NCT02721173
Locations
🇮🇳

AIIMS, Bhubaneswar, Bhubaneswar, Odisha, India

Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne Vulgaris

First Posted Date
2016-03-23
Last Posted Date
2017-02-15
Lead Sponsor
Ache Laboratorios Farmaceuticos S.A.
Registration Number
NCT02716090

Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris

Phase 3
Completed
Conditions
Acne
Interventions
First Posted Date
2016-01-08
Last Posted Date
2020-06-23
Lead Sponsor
Actavis Inc.
Target Recruit Count
1001
Registration Number
NCT02651220
Locations
🇧🇿

Site 117, Belize City, Belize

🇺🇸

Site 103, Mesa, Arizona, United States

🇺🇸

Site 112, Anaheim, California, United States

and more 17 locations

Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne

Phase 1
Completed
Conditions
Acne
Interventions
First Posted Date
2015-11-01
Last Posted Date
2019-09-24
Lead Sponsor
Lee's Pharmaceutical Limited
Target Recruit Count
245
Registration Number
NCT02593383
Locations
🇨🇳

Institute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, China

Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris

First Posted Date
2015-08-17
Last Posted Date
2021-11-02
Lead Sponsor
Padagis LLC
Target Recruit Count
903
Registration Number
NCT02525549

Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

Phase 1
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2015-04-08
Last Posted Date
2017-05-04
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
753
Registration Number
NCT02411942

Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2014-02-27
Last Posted Date
2017-03-28
Lead Sponsor
Galderma R&D
Target Recruit Count
417
Registration Number
NCT02073448
Locations
🇯🇵

Galderma investigational site, Saitama, Japan

A Long Term Study of GK530G in Subjects With Acne Vulgaris

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2013-07-29
Last Posted Date
2017-03-28
Lead Sponsor
Galderma R&D
Target Recruit Count
436
Registration Number
NCT01910064
Locations
🇯🇵

Galderma investigational site, Fukuoka, Japan

Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo® and Both to a Placebo Control in the Treatment of Acne Vulgaris

Phase 1
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2012-12-05
Last Posted Date
2017-05-04
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
2008
Registration Number
NCT01742637
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