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

NCT06425900 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: DCS-115-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment.

  Week 12

Secondary Outcomes (1)

• The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.

  Week 12

Study Arms (1)

Winlevi (Clascoterone ) cream 1%

EXPERIMENTAL

Drug: Winlevi (Clascoterone) cream 1%

Interventions

Winlevi (Clascoterone) cream 1% DRUG

Dosed twice daily (BID)

Winlevi (Clascoterone ) cream 1%

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female or male subjects age 18-35 years.
• Subjects of all Fitzpatrick skin types.
• Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.
• Subjects with oily facial skin.
• Subjects who agree to use only the study product and nothing else to the face.
• 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.
• Subjects agree not to introduce any new skin care products during the study.
• No known medical conditions that, in the investigator's opinion, may interfere with study participation.
• Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
• Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
• Subjects in generally good physical and mental health.

You may not qualify if:

• Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics.
• Subjects who are not willing to use the assigned study product to their face as instructed.
• Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.
• Subjects who have used any OTC products on the face for 2 weeks.
• Subjects with clinically significant unstable medical disorders.
• Subjects who are unwilling or unable to comply with the requirements of the protocol.
• 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.
• Subjects currently participating in any other clinical trial.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, 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

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 23, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)