Trial | NCT01784133  Report issue

Title

A Twelve Week Safety and Efficacy Study in Rosacea
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    omiganan ...

  • Study Participants

    240
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
Study Started
Mar 31
2013
Primary Completion
Mar 31
2014
Last Update
May 20
2015
Estimate

Drug omiganan

Drug placebo

omiganan low dose Active Comparator

omiganan low dose once daily application for 12 weeks

omiganan mid dose Active Comparator

omiganan mid dose once daily application for 12 weeks

omiganan high dose Active Comparator

omiganan high dose once daily application for 12 weeks

Vehicle group Placebo Comparator

Vehicle once daily application for 12 weeks

Criteria 

Inclusion Criteria:

diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion Criteria:

nodular rosacea or subtype 3
clinically significant abnormal findings that would interfere with study objectives
No Results Posted