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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 5, 2017

Interventions

  • Drug: CLS001 (Omiganan)
    • Topical gel
  • Drug: Vehicle
    • Vehicle Gel

Arms, Groups and Cohorts

  • Experimental: Treatment
    • CLS001 (Omiganan) gel applied once daily
  • Placebo Comparator: Vehicle Gel
    • Vehicle gel applied once daily

Clinical Trial Outcome Measures

Primary Measures

  • Change in Inflammatory Lesion Count From Baseline to Week 12
    • Time Frame: 12 weeks
    • Change from Baseline to Week 12 in Inflammatory Lesion Count
  • Percentage of Participants Who Achieved 2 Grade IGA Reduction.
    • Time Frame: 12 weeks
    • 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).

Secondary Measures

  • Change in the Number of Inflammatory Lesions From Baseline at Week 9
    • Time Frame: 9 weeks
    • The absolute change in inflammatory lesions from baseline to Week 9
  • Change in the Number of Inflammatory Lesions From Baseline at Week 6
    • Time Frame: 6 weeks
    • The absolute change in inflammatory lesions from baseline to Week 6
  • Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
    • Time Frame: 9 Weeks
    • 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).
  • Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
    • Time Frame: 6 Weeks
    • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maruho Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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