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

Launched by SUN PHARMACEUTICAL INDUSTRIES LIMITED · May 21, 2024

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.