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Completed

NCT Number: NCT02571998

A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris

The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
  • Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
  • Subjects with ≥ 30 facial inflammatory lesions

Exclusion criteria

  • Subjects with < 10 or > 75 facial non-inflammatory lesions
  • Subjects with > 3 facial nodular or cystic lesions at Baseline
  • Standard exclusion criteria

Treatment and study plan

Omiganan (CLS001) Topical Gel

Drug

Vehicle Topical Gel

Drug

Primary outcomes

  1. Absolute change from baseline in inflammatory lesion counts at week 12

    Time frame: 12 weeks

Secondary outcomes

  1. Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions

    Time frame: 12 weeks

  2. Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit

    Time frame: 12 weeks

  3. Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit

    Time frame: 12 weeks

  4. Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Mar 27, 2017

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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