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

Running, not enrolling · Phase 4

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT06425900

Run by

Sun Pharmaceutical Industries Limited

People needed

10

Starts

2024-07-01

Expected to finish

2026-03-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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