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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 Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2007-01-15
Last Posted Date
2021-02-18
Lead Sponsor
Galderma R&D
Target Recruit Count
1670
Registration Number
NCT00421993
Locations
🇺🇸

UTSW Medical Center at Dallas, Dallas, Texas, United States

🇺🇸

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States

🇺🇸

Dolby Research, LLC, Baton Rouge, Louisiana, United States

and more 58 locations

Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Phase 3
Completed
Conditions
Acne Vulgaris
Interventions
Drug: Benzoyl Peroxide Gel 2.5%
Drug: Gel Vehicle
First Posted Date
2007-01-15
Last Posted Date
2024-04-15
Lead Sponsor
Galderma R&D
Target Recruit Count
1668
Registration Number
NCT00422240
Locations
🇺🇸

Miller MD, San Antonio, Texas, United States

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