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CLINICAL TRIALS PROFILE FOR ADAPALENE; BENZOYL PEROXIDE
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505(b)(2) Clinical Trials for adapalene; benzoyl peroxide
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| 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 | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for adapalene; benzoyl peroxide
| 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. |
| NCT00421993 | A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris | Completed | Galderma | Phase 3 | 2006-10-01 | This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks. |
| NCT00422240 | Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris | Completed | Galderma | Phase 3 | 2006-06-01 | This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks. |
| NCT00441415 | Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris | Completed | Galderma | Phase 3 | 2007-02-01 | The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period. |
| NCT00446043 | A Long-Term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris | Completed | Galderma | Phase 3 | 2004-02-01 | This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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