What are the clinical trials for Clevatess?

Understanding Clinical Trials for Clevatess

What are the clinical trials for Clevatess? Clevatess (clascoterone) has undergone extensive clinical testing to establish its safety and efficacy as a topical treatment for acne vulgaris in patients 12 years and older.

Phase III Clinical Studies

The primary clinical evidence for Clevatess comes from two pivotal Phase III randomized, double-blind, vehicle-controlled trials (CB-03-01/25 and CB-03-01/26). These studies evaluated the effectiveness of clascoterone cream 1% in treating facial acne over a 12-week treatment period.

Study Design and Participants

Both trials enrolled over 1,400 patients combined, ranging from 9 to 58 years of age, with moderate to severe acne vulgaris. Participants were randomized to receive either Clevatess cream 1% or a matching vehicle (placebo) cream twice daily.

Primary Efficacy Endpoints

The clinical trials measured success using two co-primary endpoints:

- Investigator Global Assessment (IGA): Achievement of "clear" or "almost clear" skin with at least a 2-grade improvement from baseline

- Absolute change in inflammatory lesion count from baseline to week 12

- Absolute change in non-inflammatory lesion count from baseline to week 12

Clinical Trial Results

In both studies, Clevatess demonstrated statistically significant improvements compared to vehicle. Approximately 18-21% of patients achieved treatment success (clear or almost clear skin) versus 9-10% with placebo. Significant reductions in both inflammatory and non-inflammatory lesions were observed as early as week 2.

Safety Profile

The clinical trials established Clevatess as well-tolerated, with the most common adverse reactions being local skin reactions including erythema, scaling, and dryness at the application site.

For detailed information about ongoing studies or additional clinical data, consult with your healthcare provider or visit ClinicalTrials.gov for the most current research updates.