Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.

Criteria

Inclusion Criteria:

• Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.

• Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.

• An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria:

• Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)

• Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)

• Subjects with more than 2 facial nodulocystic lesions