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A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel for the Treatment of Acne Vulgaris. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel for the Treatment of Acne Vulgaris.

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study, Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% to CABTREO (Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide) Topical Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris.

NCT06673641•Sun Pharmaceutical Industries, Inc.

View on ClinicalTrials.gov

Summary

To demonstrate the efficacy, therapeutic equivalence and safety of Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel in the treatment of acne vulgaris.

Detailed Description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide topical gel 0.15%;3.1%;1.2% to CABTREO (Clindamycin Phosphate, Adapalene, And Benzoyl Peroxide) topical gel in the treatment of acne vulgaris.

Eligibility

Age

12 - 40 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male or nonpregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
•Subjects who are 18 years of age or older must have provided IRB approved written informed consent.
•Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
•Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.

Exclusion Criteria

•Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
•Subjects with a history of hypersensitivity or allergy to clindamycin phosphate, benzoyl peroxide, adapalene, retinoids and/or any of the study medication ingredients.
•Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
•Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with the diagnosis or assessment of acne vulgaris.

Locations (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Key Dates

Start Date

May 13, 2024

Primary Completion Date

September 3, 2024

Completion Date

September 3, 2024

Last Updated

November 5, 2024

Enrollment

382

ACTUAL participants

Conditions

Acne Vulgaris

Interventions

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2%

DRUG

CABTREO Topical Gel

DRUG

Placebo Control

DRUG

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107

Acne Vulgaris

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RECRUITINGPHASE1/PHASE2

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795

Acne Vulgaris

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RECRUITINGNA

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel for the Treatment of Acne Vulgaris.

Inclusion Criteria

Exclusion Criteria

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

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