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

Acne Vulgaris Clinical Trial

Official title:

Histologic and LCMS Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1%

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425900
• Other study ID #: DCS-115-22
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Sun Pharmaceutical Industries Limited
• Contact: Head Clinical development
• Phone: 9122 66455645
• Email: Clinical.Trial[@]sunpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Winlevi (Clascoterone) cream 1%
Dosed twice daily (BID)

Locations

Country	Name	City	State
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Week 12
Secondary	The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.		Week 12