A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Acne Vulgaris

Maruho Co., Ltd.20 sites in 1 country327 target enrollmentApril 2014

ConditionsAcne Vulgaris

InterventionsCLS001 Topical Gel Vehicle CLS001 Topical Gel

DrugsCLS001 Topical Gel CLS001 Topical Gel Vehicle

Overview

Phase: Phase 2
Intervention: CLS001 Topical Gel Vehicle
Conditions: Acne Vulgaris
Sponsor: Maruho Co., Ltd.
Enrollment: 327
Locations: 20
Primary Endpoint: Change in inflammatory lesion count from Baseline
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

November 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maruho Co., Ltd.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Vehicle Gel

Intervention: CLS001 Topical Gel Vehicle

CLS001 topical gel 1%

Topical application once daily

Intervention: CLS001 Topical Gel

CLS001 topical gel 1.75%

Topical application once daily

Intervention: CLS001 Topical Gel

CLS001 topical gel 2.5%

Topical application once daily

Intervention: CLS001 Topical Gel

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(1, 3, 6, 9 and 12 weeks)
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions(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(1, 3, 6, 9, and 12 weeks)
Percentage of subjects with a 2 grade reduction in the IGA at each visit(1, 3, 6, 9, and 12 weeks)