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

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ClinicalTrials.gov Identifier: NCT02571998
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Omiganan (CLS001) Topical Gel Drug: Vehicle Topical Gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Treatment
Omiganan (CLS001) Topical Gel applied once daily
Drug: Omiganan (CLS001) Topical Gel
Placebo Comparator: Vehicle Gel
Vehicle Topical Gel applied once daily
Drug: Vehicle Topical Gel



Primary Outcome Measures :
  1. Absolute change from baseline in inflammatory lesion counts at week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571998


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Sponsors and Collaborators
Maruho Co., Ltd.

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02571998     History of Changes
Other Study ID Numbers: CLS001-CO-PR-009
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases