A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascot… (NCT06425900) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients
United States10 participantsStarted 2024-07-01
Plain-language 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
Who can participate
Age range18 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
What they're measuring
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.
. 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.