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

Combination Treatment of Winlevi With Duac Gel in Patients With Acne Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Winlevi (clascoterone) 1% & Duac gel

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

  1. postmenopausal for at least 12 months prior to study drug administration;
  2. without a uterus and/or both ovaries; or
  3. Has been surgically sterile for at least 6 months prior to study drug administration.

• Reliable methods of contraception are:

  1. Hormonal methods or intrauterine device in use > 90 days prior to study drug administration;
  2. Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
  3. 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.

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Winlevi (clascoterone) 1% & Duac gel	Drug: Winlevi (clascoterone) 1% & Duac gel; Participants will use Winlevi (clascoterone) 1% and Duac gel as per label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" erythema at weeks 4,8,12 and 16	Week 4,8,12,16
Tolerability Measures of Dryness Based on 5-point Severity Scale	The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" dryness at weeks 4,8,12 and 16.	Week 4,8,12,16
Tolerability Measures of Peeling Based on 5-point Severity Scale	The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. The information presented represents the "Percentage of participant" with "Absent or Trace" peeling at weeks 4,8,12 and 16	Week 4,8,12,16
Assessment of Skin Oiliness Based on 5-point Severity Scale	The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" oiliness at weeks 4,8,12 and 16	Week 4,8,12,16
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale	The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" burning at weeks 4,8,12 and 16	Week 4,8,12,16
Tolerability Measures of Pruritus Based on 6-point Severity Scale	The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" Pruritus at weeks 4,8,12 and 16	Week 4,8,12,16

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: WIN2023

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.: No