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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02571998

Enrollment

320

Registered

2015-10-08

Start date

2015-10-31

Completion date

2016-08-31

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DRUGOmiganan (CLS001) Topical Gel

DRUGVehicle Topical Gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in inflammatory lesion counts at week 12	12 weeks

Secondary

Measure	Time frame
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions	12 weeks
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit	12 weeks
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026