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.

NCT ID: NCT06673641

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2024-09-03

Brief 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

CABTREO Topical Gel

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Group Type: ACTIVE_COMPARATOR

CABTREO Topical Gel

Intervention Type: DRUG

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Placebo Control

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: DRUG

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Interventions

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

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Intervention Type: DRUG

CABTREO Topical Gel

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Intervention Type: DRUG

Placebo Control

The study medication was applied once daily to cover the entire face after washing, avoiding the eyes, lips, angles of the nose, and mucous membranes for 84 consecutive days.

Intervention Type: DRUG

Other Intervention Names

Test Product; Reference Product; Vehicle

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Yantovskiy

Role: STUDY_DIRECTOR

Taro Pharmaceuticals, Inc.

Locations

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Countries

United States

Other Identifiers

ABCG-2407

Identifier Type: -

Identifier Source: org_study_id