A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

A Phase 1, Open Label, Multiple Center Study to Evaluate the Pharmacokinetics of Once-Daily CLS001 Topical Gel Under Maximal Use Conditions Administered for 21 Days in Subjects With Papulopustular Rosacea

The purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.

Inclusion Criteria:

• A diagnosis of papulopustular rosacea
• Grade 3 or 4 on the 5-point Investigator Global Assessment scale
• Presence of telangiectasia

Exclusion Criteria:

• steroid rosacea or subtype 3 (phymatous rosacea)
• clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject.
• nodular rosacea (lesions greater than 5mm with more than 2 modules)