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

January 19, 2026 updated by: Sun Pharmaceutical Industries Limited

Histologic and Liquid Chromatography Mass Spectrometry (LCMS) Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1%

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Winlevi (Clascoterone ) cream 1%
Drug: Winlevi (Clascoterone) cream 1%
Dosed twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCS-115-22

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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