Clinical Trial: A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Cutanea Life Sciences, Inc.

Current Primary Outcome: Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5 [ Time Frame: 24 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: incidence of adverse events [ Time Frame: 24 days ]

Original Secondary Outcome: Same as current

Information By: Cutanea Life Sciences, Inc.

Dates:
Date Received: November 27, 2013
Date Started: January 2014
Date Completion:
Last Updated: April 11, 2014
Last Verified: April 2014