Clascoterone Cream for Acne

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Sun Pharmaceutical Industries Limited

Must not be taking: Antibiotics, Retinoids, Steroids, others

Disqualifiers: Severe acne, Pregnancy, Dermatological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. A newly FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production. This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval. This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction.

Eligibility Criteria

This trial is for individuals with acne, aiming to test if Clascoterone Cream 1% can reduce skin oil production. Participants should have a diagnosis of acne and be willing to apply the cream as directed.

Inclusion Criteria

I am 12 years old or older.

Subjects are dependable and able to follow directions and willing to comply with the schedule of visits

No known medical conditions that, in the investigator's opinion, may interfere with study participation

Exclusion Criteria

I am willing to use the study product on my face as instructed.

I am willing and able to follow the study's requirements.

Subjects with any known allergies or sensitivities to the study acne products

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply clascoterone cream 1% to evaluate its effect on sebum reduction

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Clascoterone Cream 1%

Trial Overview The study tests Clascoterone Cream 1%, an FDA-approved medication for acne that may work by reducing sebum (skin oil) production, which could starve and kill the bacteria responsible for acne.

Participant Groups

Group I: Winlevi (clascoterone) 1% cream Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution