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OpenTrials
Completed

NCT Number: NCT01784133

A Twelve Week Safety and Efficacy Study in Rosacea

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.

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research Inc., Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omiganan

Drug

Placebo

Drug

Primary outcomes

  1. Change in inflammatory lesion count

    Time frame: 0, 1, 3, 6, 9 and 12 weeks

Secondary outcomes

  1. Success on IGA defined as clear or almost clear

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Feb 5, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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