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

Maruho

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: CLS001 Topical Gel Vehicle; Drug: CLS001 Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066545

CLS001-CO-PR-003

Details and patient eligibility

About

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

Enrollment: 327 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

327 participants in 4 patient groups, including a placebo group

Vehicle Gel

Placebo Comparator group

Treatment:

Drug: CLS001 Topical Gel Vehicle

CLS001 topical gel 1%

Experimental group

Description:

Topical application once daily

Treatment:

Drug: CLS001 Topical Gel

CLS001 topical gel 1.75%

Experimental group

Description:

Topical application once daily

Treatment:

Drug: CLS001 Topical Gel

CLS001 topical gel 2.5%

Experimental group

Description:

Topical application once daily

Treatment:

Drug: CLS001 Topical Gel