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.

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2%; Drug: CABTREO Topical Gel; Drug: Placebo Control

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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Hawthorne, New York, United States, 10532
      • Taro Pharmaceuticals USA Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Test Product
Active Comparator: 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.	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.; Other Names: Reference Product
Placebo Comparator: 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.	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.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the Therapeutic Equivalence & Safety of the Investigational Product	Percent change in the inflammatory (papules and pustules) and the non-inflammatory (open and closed comedones) lesion counts.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Director: Natalie Yantovskiy, Taro Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: November 2, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Bacterial Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Dermatologic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Protein Synthesis Inhibitors; Adapalene; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
• Other Study ID Numbers: ABCG-2407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes