A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.

Criteria

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)