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

Phase 2CompletedNCT02066545

Maruho Co., Ltd.327 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

327

Conditions

Acne Vulgaris

Interventions

CLS001 Topical GelDRUG

CLS001 Topical Gel VehicleDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (20)

Encino Research Center

Encino, California, United States

Skin Surgery Medical Group, Inc.

Outcomes

Primary Outcomes

Change in inflammatory lesion count from Baseline

Time frame: 6, 9 and 12 weeks

Secondary Outcomes

Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions

Time frame: 1, 3, 6, 9 and 12 weeks

Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions

Time frame: 1, 3, 6, 9 and 12 weeks

Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit

Time frame: 1, 3, 6, 9, and 12 weeks

Percentage of subjects with a 2 grade reduction in the IGA at each visit

Time frame: 1, 3, 6, 9, and 12 weeks

Data from ClinicalTrials.gov

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