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.

NCT06673641 | Completed Phase 1 FDA Drug

• 1 other identifier: ABCG-2407
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

EXPERIMENTAL

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%

CABTREO Topical Gel

ACTIVE COMPARATOR

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

Placebo Control

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Test Product

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

CABTREO Topical Gel 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.

Also known as: Reference Product

CABTREO Topical Gel

Placebo Control 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.

Also known as: Vehicle

Placebo Control

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Natalie Yantovskiy

  Taro Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: May 13, 2024
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)