A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne

NCT06415305 | Completed Phase 4 Results FDA Drug

• 1 other identifier: WINSCO - 2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation. Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of This Study is the Percent of Patients Who Achieved Clear (0) or Almost Clear (1) on IGA Scale at Week 16

  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 52

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

  Week 52

Study Arms (1)

Winlevi (clascoterone) 1% cream

EXPERIMENTAL

Drug: Winlevi (clascoterone) 1% cream

Interventions

Winlevi (clascoterone) 1% cream DRUG

Dosed twice daily (BID)

Winlevi (clascoterone) 1% cream

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 (Fitzpatrick skin types IV, V, VI), 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 (Section 5.2).
• iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
• 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.

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

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
• Restriction Type: GT60
• 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: May 10, 2024
• First Posted: May 16, 2024
• Study Start: September 1, 2023
• Primary Completion: April 17, 2024
• Study Completion: January 30, 2025
• Last Updated: January 16, 2026
• Results First Posted: May 7, 2025

Record last verified: 2025-04

Locations

US (1)