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CompletedNCT01784133Updated May 20, 2015

A Twelve Week Safety and Efficacy Study in Rosacea

A Phase 2 interventional study of omiganan and placebo in Papulopustular Rosacea, sponsored by Maruho Co., Ltd.. Completed at 17 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Maruho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Papulopustular Rosacea

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Keywords

  • rosacea
03

In context

Rosacea

231 studies on the registry are indexed under Rosacea; 20 are open to participants now.

This study's enrollment of 240 is above the median of 61 across 199 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion criteria

Exclusion Criteria:

  • nodular rosacea or subtype 3
  • clinically significant abnormal findings that would interfere with study objectives
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    omiganan mid dose

    omiganan mid dose once daily application for 12 weeks

    Drug: omiganan

  • Active comparator
    omiganan high dose

    omiganan high dose once daily application for 12 weeks

    Drug: omiganan

  • Placebo comparator
    Vehicle group

    Vehicle once daily application for 12 weeks

    Drug: placebo

  • Active comparator
    omiganan low dose

    omiganan low dose once daily application for 12 weeks

    Drug: omiganan

Interventions

06

What researchers measure

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

07

Study locations

17 sites
  • Radiant Research Inc.
    Birmingham, Alabama 35209, United States
  • ATS Clinical Research
    Santa Monica, California 90404, United States
  • The Savin Center, PC
    New Haven, Connecticut 06511, United States
  • Skin Care Research, Inc
    Boca Raton, Florida 33486, United States
  • Dunedin Research Specialists
    Dunedin, Florida 34698, United States
  • North Florida Dermatology Associates
    Jacksonville, Florida 32204, United States
  • Dawes Fretzin Clinical Research Group
    Indianapolis, Indiana 46256, United States
  • Grekin Skin Institute
    Warren, Michigan 48088, United States
  • Rochester General Medical Group Center for Dermatology at Linden Oaks
    Rochester, New York 14625, United States
  • Derm Research Center of NY Inc.
    Stoney Brook, New York 11790, United States
  • Wake Resarch
    Raleigh, North Carolina 27612, United States
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
  • TriCities Skin and Cancer
    Johnson City, Tennessee 37674, United States
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
  • Progressive Clinical Research, PA
    San Antonio, Texas 78229, United States
  • Dermatology Research Center
    Salt Lake City, Utah 84117, United States
  • Virginia Clinical Research Inc.
    Norfolk, Virginia 23507, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01784133
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
Feb 5, 2013
Start date
Mar 2013
Primary completion
Mar 2014
Last update
May 20, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Omiganan

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