A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients

NCT ID: NCT06425900

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-03-31

Brief Summary

to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Winlevi (Clascoterone ) cream 1%

Group Type: EXPERIMENTAL

Winlevi (Clascoterone) cream 1%

Intervention Type: DRUG

Dosed twice daily (BID)

Interventions

Winlevi (Clascoterone) cream 1%

Dosed twice daily (BID)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female or male subjects age 18-35 years.

2. Subjects of all Fitzpatrick skin types.

3. Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.

4. Subjects with oily facial skin.

5. Subjects who agree to use only the study product and nothing else to the face.

6. Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face.

7. Subjects agree not to introduce any new skin care products during the study.

8. No known medical conditions that, in the investigator's opinion, may interfere with study participation.

9. Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."

10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.

11. Subjects in generally good physical and mental health.

Exclusion Criteria

1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics.

2. Subjects who are not willing to use the assigned study product to their face as instructed.

3. Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.

4. Subjects who have used any OTC products on the face for 2 weeks.

5. Subjects with clinically significant unstable medical disorders.

6. Subjects who are unwilling or unable to comply with the requirements of the protocol.

7. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.

8. Subjects currently participating in any other clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Countries

United States

Other Identifiers

DCS-115-22

Identifier Type: -

Identifier Source: org_study_id