Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Vehicle; Drug: CLS001 (Omiganan)

• Study Type: Interventional
• Enrollment (Actual): 463
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia
  • Victoria
    • Carlton, Victoria, Australia
    • East Melbourne, Victoria, Australia
• Canada
  • Ontario
    • Hamilton, Ontario, Canada
    • Toronto, Ontario, Canada
• France
  • Brest, France
  • Nancy, France
  • Nice, France
  • Rouen, France
  • Thionville, France
• Germany
  • Augsburg, Germany
  • Berlin, Germany
  • Bochum, Germany
  • Darmstadt, Germany
  • Dresden, Germany
  • Dulmen, Germany
  • Frankfurt, Germany
  • Ibbenbueren, Germany
  • Lubeck, Germany
  • Mahlow, Germany
  • Munster, Germany
• Netherlands
  • Rotterdam, Netherlands
• New Zealand
  • Hamilton, New Zealand
• Sweden
  • Gothenburg, Sweden
• United Kingdom
  • Lanarkshire, United Kingdom
  • Leeds, United Kingdom
  • Manchester, United Kingdom
  • Surrey, United Kingdom
• United States
  • California
    • Fremont, California, United States
  • Florida
    • Miami, Florida, United States
    • Miramar, Florida, United States
    • Tampa, Florida, United States
  • Illinois
    • Arlington Heights, Illinois, United States
  • Indiana
    • Carmel, Indiana, United States
  • Michigan
    • Fort Gratiot, Michigan, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • New York, New York, United States
    • Stony Brook, New York, United States
  • Texas
    • Dallas, Texas, United States
    • San Antonio, Texas, United States
  • Virginia
    • Charlottesville, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy, male and non-pregnant female subjects, 18 years of age or older.
2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
3. Subjects with the presence of telangiectasia at Baseline.
4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea.
3. Standard exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; CLS001 (Omiganan) gel applied once daily	Drug: CLS001 (Omiganan); Topical gel
Placebo Comparator: Vehicle Gel; Vehicle gel applied once daily	Drug: Vehicle; Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammatory Lesion Count From Baseline to Week 12	Change from Baseline to Week 12 in Inflammatory Lesion Count	12 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction.	Percentage of participants who achieved 2 grade IGA reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Number of Inflammatory Lesions From Baseline at Week 9	The absolute change in inflammatory lesions from baseline to Week 9	9 weeks
Change in the Number of Inflammatory Lesions From Baseline at Week 6	The absolute change in inflammatory lesions from baseline to Week 6	6 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.	Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).	9 Weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.	Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).	6 Weeks

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): July 5, 2017
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 31, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: CLS001-CO-PR-004