Adapalene

Generic Name: Adapalene

Brand Names: Cabtreo, Differin, Epiduo, Panoxyl, Tactupump

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₂₈O_₃

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

Clinical Trials

A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Combination Product: FCD105
Drug: 0.3% Adapalene Foam
Other: Vehicle Foam
Drug: 3% Minocycline Foam

First Posted Date: 2019-09-26

Last Posted Date: 2021-02-05

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 446

Registration Number: NCT04104685

Locations: 🇺🇸
Foamix Institution #126, Baton Rouge, Louisiana, United States
🇺🇸
Foamix Institution #107, Hialeah, Florida, United States
🇺🇸
Foamix Institution #132, San Diego, California, United States

and more 32 locations

Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris

Phase 4

Conditions: Acne Vulgaris

Interventions: Drug: Vitamin D analog
Drug: Adapalene

First Posted Date: 2019-03-07

Last Posted Date: 2019-03-12

Lead Sponsor: Assiut University

Target Recruit Count: 80

Registration Number: NCT03866447

The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne

Not Applicable

Withdrawn

Conditions: Acne

Interventions: Drug: Neutrogena ® Light Therapy Acne Mask (MASK)
Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene

First Posted Date: 2018-08-29

Last Posted Date: 2020-05-20

Lead Sponsor: NYU Langone Health

Registration Number: NCT03650881

Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Adapalene Gel 0.3%
Drug: Differin 0.3% Topical Gel
Drug: Adapalene Gel 0.3% Vehicle Placebo

First Posted Date: 2018-08-28

Last Posted Date: 2019-04-26

Lead Sponsor: Aleor Dermaceuticals Limited

Target Recruit Count: 755

Registration Number: NCT03650361

Locations: 🇺🇸
FXM Research Miramar, Miramar, Florida, United States
🇺🇸
Moore Clinical Research Institute, Inc., Tampa, Florida, United States
🇺🇸
Unison Center for Clinical Trials, Sherman Oaks, California, United States

and more 4 locations