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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

Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Phase 1
Completed
Conditions
Skin Manifestations
Interventions
First Posted Date
2010-01-12
Last Posted Date
2022-08-25
Lead Sponsor
Galderma R&D
Target Recruit Count
75
Registration Number
NCT01046565
Locations
🇺🇸

Thomas J. Stephens & Associates, Inc., Carrollton, Texas, United States

Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Phase 1
Completed
Conditions
Skin Manifestations
Interventions
First Posted Date
2010-01-12
Last Posted Date
2022-08-01
Lead Sponsor
Galderma R&D
Target Recruit Count
69
Registration Number
NCT01046396
Locations
🇺🇸

Thomas J. Stephens & Associates, Inc., Colorado Springs, Colorado, United States

Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

First Posted Date
2009-06-23
Last Posted Date
2015-05-20
Lead Sponsor
Stiefel, a GSK Company
Target Recruit Count
52
Registration Number
NCT00926367
Locations
🇺🇸

cyberDERM, Broomall, Pennsylvania, United States

Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2009-06-12
Last Posted Date
2012-02-15
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
26
Registration Number
NCT00919191
Locations
🇺🇸

Skin Study Center, Broomall, Pennsylvania, United States

Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes

Phase 4
Completed
Conditions
P Acnes Colonization
Interventions
First Posted Date
2009-05-22
Last Posted Date
2022-08-01
Lead Sponsor
Galderma R&D
Target Recruit Count
30
Registration Number
NCT00907101
Locations
🇺🇸

Skin Study Center, Broomall, Pennsylvania, United States

A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2009-04-24
Last Posted Date
2016-12-13
Lead Sponsor
Stiefel, a GSK Company
Target Recruit Count
50
Registration Number
NCT00887484
Locations
🇦🇷

Centro de Investigación y Prevencion de Enfermidades Cardiovasculares, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

🇦🇷

Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

🇦🇷

LUMIPIEL - Centro Dermatológico, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

and more 1 locations

Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

Phase 3
Completed
Conditions
Acne
Interventions
Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Drug: Adapalene-BPO 3-hour daily application before bedtime
Drug: Adapalene-BPO Gel every other day application
First Posted Date
2009-04-17
Last Posted Date
2021-02-18
Lead Sponsor
Galderma R&D
Target Recruit Count
123
Registration Number
NCT00883233
Locations
🇨🇦

Galderma Investigational Site, Montreal, Quebec, Canada

Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Phase 4
Terminated
Conditions
Acne Vulgaris
Interventions
First Posted Date
2009-01-26
Last Posted Date
2012-09-12
Lead Sponsor
Allergan
Target Recruit Count
165
Registration Number
NCT00829049

Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2008-12-11
Last Posted Date
2012-03-20
Lead Sponsor
Stiefel, a GSK Company
Target Recruit Count
169
Registration Number
NCT00807014
Locations
🇪🇸

Clínica Universitaria de Navarra, Pamplona, Spain

🇪🇸

Hospital del Mar, Barcelona, Spain

🇪🇸

Hospital Germans Trias I Pujol, Badalona, Spain

and more 5 locations

Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2008-07-14
Last Posted Date
2012-02-15
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
25
Registration Number
NCT00714714
Locations
🇺🇸

A J&J CPPW Investigational Site, Broomall, Pennsylvania, United States

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