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NCT Number: NCT06425900

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Winlevi (Clascoterone) cream 1%

Drug

Dosed twice daily (BID)

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.

    Time frame: 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.

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 23, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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