You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 20, 2024

CLINICAL TRIALS PROFILE FOR BENZOYL PEROXIDE


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Benzoyl Peroxide

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 Dosage NCT02058628 ↗ Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris Completed GlaxoSmithKline Phase 4 2014-02-21 This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.
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Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne Withdrawn New York University School of Medicine N/A 2018-08-07 This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of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.
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 Withdrawn NYU Langone Health N/A 2018-08-07 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.
OTC NCT04021524 ↗ BPO vs Hibiclens Soap for Surgical Preparation Unknown status University of Washington Phase 4 2018-09-10 This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for 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.
NCT00377000 ↗ A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels. Completed Sanofi Phase 4 2005-11-01 Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Benzoyl Peroxide

Condition Name

Condition Name for Benzoyl Peroxide
Intervention Trials
Acne Vulgaris 73
Acne 14
Foot Dermatoses 3
Surgical Site Infection 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Benzoyl Peroxide
Intervention Trials
Acne Vulgaris 88
Skin Diseases 4
Foot Dermatoses 3
Infections 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Benzoyl Peroxide

Trials by Country

Trials by Country for Benzoyl Peroxide
Location Trials
United States 241
Canada 23
India 15
Germany 14
China 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Benzoyl Peroxide
Location Trials
California 19
Texas 18
Pennsylvania 16
Florida 16
North Carolina 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Benzoyl Peroxide

Clinical Trial Phase

Clinical Trial Phase for Benzoyl Peroxide
Clinical Trial Phase Trials
Phase 4 47
Phase 3 30
Phase 2/Phase 3 1
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Benzoyl Peroxide
Clinical Trial Phase Trials
Completed 82
Recruiting 8
Unknown status 8
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Benzoyl Peroxide

Sponsor Name

Sponsor Name for Benzoyl Peroxide
Sponsor Trials
GlaxoSmithKline 20
Galderma 14
Galderma R&D 14
[disabled in preview] 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Benzoyl Peroxide
Sponsor Trials
Industry 111
Other 50
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.