Clascoterone Cream for Acne

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Sun Pharmaceutical Industries Limited

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation. Data is limited for skin of color patients in Phase III registration trials. Data is limited because there a few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.

Eligibility Criteria

This trial is for individuals with skin of color who are experiencing acne. It's designed to add evidence on how effective and safe Clascoterone Cream 1% is in treating acne specifically in this group, as past studies haven't focused much on them.

Inclusion Criteria

I am a woman who can have children, have a negative pregnancy test, and will use birth control during the study.

I can understand the study's requirements and can sign the consent forms.

I am 12 years or older and have a darker skin tone.

+2 more

Exclusion Criteria

Allergy or sensitivity to any component of the test medications

I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable birth control.

Subjects who have not complied with the proper wash-out periods for prohibited medications

+5 more

Participant Groups

The study tests the efficacy and safety of Winlevi (clascoterone) 1% cream in treating acne among patients with skin of color. The goal is to provide real-world data that complements previous Phase III trials.

1Treatment groups

Experimental Treatment

Group I: Winlevi (clascoterone) 1% creamExperimental Treatment1 Intervention