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

Maruho

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Omiganan (CLS001) Topical Gel; Drug: Vehicle Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02571998

CLS001-CO-PR-009

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: Female

Ages: 12+ years old

Volunteers: No 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 exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

320 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Omiganan (CLS001) Topical Gel applied once daily

Treatment:

Drug: Omiganan (CLS001) Topical Gel

Vehicle Gel

Placebo Comparator group

Description:

Vehicle Topical Gel applied once daily

Treatment:

Drug: Vehicle Topical Gel