A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne

NCT06336629 | Completed Phase 4 Results FDA Drug

• 1 other identifier: WIN2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on Investigator Global Assessment (IGA) Scale at Week 16.

  The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne

  Week 16

Secondary Outcomes (9)

• Percent of Total Lesion Reduction at Week 16 Compared to Baseline

  Week 16

• Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline

  Week 16

• Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline.

  Week 16

• Tolerability Measures of Erythema Based on 5-point Severity Scale

  Week 4,8,12,16

• Tolerability Measures of Dryness Based on 5-point Severity Scale

  Week 4,8,12,16

Study Arms (1)

Winlevi (clascoterone) 1% & Duac gel

EXPERIMENTAL

Drug: Winlevi (clascoterone) 1% & Duac gel

Interventions

Winlevi (clascoterone) 1% & Duac gel DRUG

Participants will use Winlevi (clascoterone) 1% and Duac gel as per label

Winlevi (clascoterone) 1% & Duac gel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Outpatient, male or female subjects of any race, and at least 12 years of age or older.
• Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:
• A female is considered of childbearing potential unless she is:
• postmenopausal for at least 12 months prior to study drug administration;
• without a uterus and/or both ovaries; or
• Has been surgically sterile for at least 6 months prior to study drug administration.
• Reliable methods of contraception are:
• Hormonal methods or intrauterine device in use \> 90 days prior to study drug administration;
• Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
• Vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice).
• Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.
• ii. Facial acne IGA score of 3 or 4.
• iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

You may not qualify if:

• i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• ii. Allergy or sensitivity to any component of the test medications. iii. Subjects who have not complied with the proper wash-out periods for prohibited medications .
• iv. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.
• v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability.
• viii. Exposure to an investigational drug study within 30 days of the Baseline Visit.
• ix. Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis)

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clascoterone; clindamycin phosphate benzoyl peroxide combination

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head-Regulatory Affairs
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 29, 2024
• Study Start: November 15, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Locations

US (1)