A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients

NCT06415292 | Completed Phase 4 Results FDA Drug

• 1 other identifier: DCS-94-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment.

  The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration

  Week 2

Secondary Outcomes (1)

• Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment

  Week 2

Study Arms (2)

Winlevi (clascoterone) 1% treated

EXPERIMENTAL

Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.

Drug: Winlevi (clascoterone) 1% cream

Splitface design- No study product

NO INTERVENTION

Splitface design-no study product was applied to the untreated side of the face

Interventions

Winlevi (clascoterone) 1% cream DRUG

Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.

Winlevi (clascoterone) 1% treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who self identify as having sensitive acne prone skin.
• Female or male subjects 18+ years of age.
• Subjects with Fitzpatrick skin types I-VI.
• Subject agrees not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) or skin care products during the study.
• Subjects must be willing to use only a cleanser and sunscreen on the entire face and no other skin care products.
• Subjects must be willing to use the Winlevi study product to designated half face. No other topical acne treatment products on the entire face for the 2 week duration of the study.
• Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
• Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.
• Subject is 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, except for the conditions associated with sensitive skin.
• Subjects who are not willing to use only the assigned study product and nothing else one randomized half face, except for cleanser and sunscreen that must remain unchanged during the study. Moisturizers or topical acne treatment products should not be used during the 2 week study period on either side of the face.
• Subjects who do not agree to refrain from direct sun exposure during the study duration.
• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
• Subjects, who are pregnant, breast feeding, or planning a pregnancy.
• 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 who are currently participating in any other clinical study.
• Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
• Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day.
• Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork.
• Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study documentation.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Head-Regulatory Affairs
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Outcomes Assessor/Investigator was blinded to which side of the face received the treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients were randomized to apply treatment (winlevi 1%) to one side of the face and the other side of the face remained untreated

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: November 27, 2023
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (1)