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Last Updated: November 17, 2019

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CLINICAL TRIALS PROFILE FOR ADAPALENE

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505(b)(2) Clinical Trials for Adapalene

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT03615768 A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris Recruiting Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited Phase 3 2018-08-14 This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation NCT03615768 A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris Recruiting Lee's Pharmaceutical Limited Phase 3 2018-08-14 This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
OTC NCT03650881 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 yet recruiting New York University School of Medicine N/A 2019-03-01 This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Adapalene

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00151541 A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4% Completed Allergan Phase 3 2005-02-01 The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
NCT00160394 Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris Completed GlaxoSmithKline Phase 4 2004-12-01 Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
NCT00160394 Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris Completed Stiefel, a GSK Company Phase 4 2004-12-01 Comparing the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Adapalene

Condition Name

Condition Name for Adapalene
Intervention Trials
Acne Vulgaris 48
Acne 12
Skin Manifestations 2
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Condition MeSH

Condition MeSH for Adapalene
Intervention Trials
Acne Vulgaris 52
Skin Manifestations 2
Keratosis 1
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Clinical Trial Locations for Adapalene

Trials by Country

Trials by Country for Adapalene
Location Trials
United States 191
Canada 27
Brazil 12
India 7
Germany 5
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Trials by US State

Trials by US State for Adapalene
Location Trials
Texas 18
California 14
Florida 12
North Carolina 11
Pennsylvania 11
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Clinical Trial Progress for Adapalene

Clinical Trial Phase

Clinical Trial Phase for Adapalene
Clinical Trial Phase Trials
Phase 4 31
Phase 3 19
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Adapalene
Clinical Trial Phase Trials
Completed 46
Recruiting 9
Unknown status 5
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Clinical Trial Sponsors for Adapalene

Sponsor Name

Sponsor Name for Adapalene
Sponsor Trials
Galderma 17
Galderma Laboratories, L.P. 10
GlaxoSmithKline 6
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Sponsor Type

Sponsor Type for Adapalene
Sponsor Trials
Industry 62
Other 21
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Serving leading biopharmaceutical companies globally:

Colorcon
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