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 Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period

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): 263
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia
  • New South Wales
    • Kogarah, New South Wales, Australia
    • Liverpool, New South Wales, Australia
  • Victoria
    • Box Hill, Victoria, Australia
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada
  • Ontario
    • Courtice, Ontario, Canada
    • Peterborough, Ontario, Canada
    • Windsor, Ontario, Canada
• France
  • Grenoble, France
  • Nantes, France
  • Quimper, France
• Germany
  • Berlin, Germany
  • Bochum, Germany
  • Bonn, Germany
  • Friedrichshafen, Germany
  • Hamburg, Germany
  • Koeln, Germany
  • Lingen, Germany
  • Monchengladbach, Germany
  • Osnabruck, Germany
  • Schweinfurt, Germany
• Netherlands
  • Nijmegen, Netherlands
• New Zealand
  • Auckland, New Zealand
• Sweden
  • Halmstad, Sweden
• United Kingdom
  • Birmingham, United Kingdom
  • London, United Kingdom
  • England
    • Bradford, England, United Kingdom
• United States
  • Arkansas
    • Fort Smith, Arkansas, United States
    • Rogers, Arkansas, United States
  • California
    • Manhattan Beach, California, United States
    • Oceanside, California, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Boynton Beach, Florida, United States
    • Miami, Florida, United States
  • Indiana
    • Plainfield, Indiana, United States
  • Massachusetts
    • Watertown, Massachusetts, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Jersey
    • Verona, New Jersey, United States
  • New York
    • New York, New York, United States
    • Stony Brook, New York, United States
  • North Carolina
    • High Point, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
  • Texas
    • Arlington, Texas, United States
    • San Antonio, Texas, 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
Placebo Comparator: Vehicle Gel; Vehicle gel applied once daily	Drug: Vehicle; Vehicle gel
Experimental: Treatment; CLS001 (Omignan) gel applied once daily	Drug: CLS001 (Omiganan); Topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Absolute Change in Inflammatory Lesion Count	Absolute change in inflammatory lesion count from baseline to Week 12.	12 weeks
Efficacy IGA: 2 Grade Reduction	Proportion of Subjects 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
Efficacy The Absolute Change in Inflammatory Lesions	The absolute change in inflammatory lesions from baseline to Week 9.	9 weeks
Efficacy The Absolute Change in Inflammatory Lesions	The absolute change in inflammatory lesions from baseline to Week 6.	6 weeks
Efficacy IGA: 2 Point Reduction	Proportion of Subjects 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
Efficacy IGA: 2 Point Reduction	Proportion of Subjects 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Adverse Events	Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events	12 weeks

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): September 5, 2017

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 7, 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-005