At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne
In Brief
A Phase 4 clinical trial evaluating Winlevi (clascoterone) 1% cream for Acne Vulgaris. Completed, enrolled 10 participants across 1 site.
Detailed Summary
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 are 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.
Study Details
Timeline
Interventions
Dosed twice daily (BID)