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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571998
• Other study ID #: CLS001-CO-PR-009
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2015
• Last updated: March 24, 2017
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Cutanea Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Omiganan (CLS001) Topical Gel

• Vehicle Topical Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in inflammatory lesion counts at week 12		12 weeks
Secondary	Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions		12 weeks
Secondary	Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit		12 weeks
Secondary	Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit		12 weeks
Secondary	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.		12 weeks