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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

Effect of Samples on Acne Treatment With Epiduo® Gel

First Posted Date
2012-01-05
Last Posted Date
2018-09-12
Lead Sponsor
Wake Forest University
Target Recruit Count
20
Registration Number
NCT01504204
Locations
🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris

Not Applicable
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2011-12-29
Last Posted Date
2011-12-29
Lead Sponsor
Actavis Mid-Atlantic LLC
Target Recruit Count
885
Registration Number
NCT01501799
Locations
🇧🇿

FXM Research International - Belize, Belize City, Belize

🇺🇸

Haber Dermatology and Cosmetic Surgery Inc., South Euclid, Ohio, United States

🇺🇸

Adult & Pediatric Dermatology, Overland Park, Kansas, United States

and more 22 locations

A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura

Phase 2
Conditions
Senile Purpura
Interventions
First Posted Date
2011-12-05
Last Posted Date
2012-04-23
Lead Sponsor
Multispecialty Aesthetic Clinical Research Organization
Target Recruit Count
20
Registration Number
NCT01485367
Locations
🇺🇸

Multispecialty Aesthetic Clinical Research Organization, Woodland Hills, California, United States

Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Phase 1
Withdrawn
Conditions
Acne Vulgaris
Interventions
Drug: Fixed Combination dapsone/adapalene Formulation A Gel
Drug: Fixed Combination dapsone/adapalene Formulation B Gel
First Posted Date
2011-08-30
Last Posted Date
2012-11-19
Lead Sponsor
Allergan
Registration Number
NCT01425320

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging

Phase 3
Completed
Conditions
Photoaging
Photodamage
Interventions
First Posted Date
2011-07-29
Last Posted Date
2017-04-06
Lead Sponsor
Galderma Brasil Ltda.
Target Recruit Count
128
Registration Number
NCT01406080
Locations
🇧🇷

Hospital de Clínicas da Universidade Federal do Paraná, Curitiba, Paraná, Brazil

🇧🇷

Santa Casa de Belo Horizonte, Belo Horizonte, Minas Gerais, Brazil

🇧🇷

Centro de Dermatologia Dona Libania, Fortaleza, Ceará, Brazil

and more 1 locations

Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2011-07-04
Last Posted Date
2013-07-08
Lead Sponsor
University of Magdeburg
Target Recruit Count
60
Registration Number
NCT01387048
Locations
🇩🇪

Clinic for Dermatology and Vereology, Central Hospital Magdeburg, Magdeburg, Saxony-Anhalt, Germany

Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

Phase 2
Completed
Conditions
Acne Scars
Interventions
First Posted Date
2010-10-01
Last Posted Date
2021-02-18
Lead Sponsor
Galderma R&D
Target Recruit Count
20
Registration Number
NCT01213199
Locations
🇺🇸

Manisha PATEL, Baltimore, Maryland, United States

Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2010-09-27
Last Posted Date
2022-08-01
Lead Sponsor
Galderma R&D
Target Recruit Count
30
Registration Number
NCT01209949
Locations
🇺🇸

Thomas J. Stephens and Associates, Carrollton, Texas, United States

Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

Phase 1
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2010-08-17
Last Posted Date
2010-11-24
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
601
Registration Number
NCT01182636
Locations
🇺🇸

Dermatology Research Associates, Los Angeles, California, United States

🇺🇸

SNBL Clinical Pharmacology Center, Inc., Baltimore, Maryland, United States

🇺🇸

Academic Dermatology Associates, Albuquerque, New Mexico, United States

and more 18 locations

Study Comparing 0.3% Adapalene Topical Gel to Differin® 0.3% Adapalene Topical Gel

Not Applicable
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2010-03-30
Last Posted Date
2010-03-30
Lead Sponsor
Actavis Mid-Atlantic LLC
Target Recruit Count
1159
Registration Number
NCT01095640
Locations
🇮🇳

L.T.M. Medical College & General Hospital, Mumbai, India

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