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Completed

NCT Number: NCT02576860

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phillip, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CLS001 (Omiganan)

Drug

Topical gel

Vehicle

Drug

Vehicle gel

Primary outcomes

  1. Efficacy Absolute Change in Inflammatory Lesion Count

    Time frame: 12 weeks

    Absolute change in inflammatory lesion count from baseline to Week 12.

  2. Efficacy IGA: 2 Grade Reduction

    Time frame: 12 weeks

    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).

Secondary outcomes

  1. Efficacy The Absolute Change in Inflammatory Lesions

    Time frame: 9 weeks

    The absolute change in inflammatory lesions from baseline to Week 9.

  2. Efficacy The Absolute Change in Inflammatory Lesions

    Time frame: 6 weeks

    The absolute change in inflammatory lesions from baseline to Week 6.

  3. Efficacy IGA: 2 Point Reduction

    Time frame: 9 Weeks

    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).

  4. Efficacy IGA: 2 Point Reduction

    Time frame: 6 Weeks

    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).

Other outcomes

  1. Safety Adverse Events

    Time frame: 12 weeks

    Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Aug 2, 2022

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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