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

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

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: CLS001 Topical Gel Vehicle; Drug: CLS001 Topical Gel

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Encino Research Center
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group, Inc.
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Pinellas Park, Florida, United States, 33781
      • Belleair Research Center
    • Tampa, Florida, United States, 33609
      • MOORE Clinical Research, Inc.
    • West Palm Beach, Florida, United States, 33401
      • Kenneth R. Beer, MD, PA
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • New York, New York, United States, 10017
      • Manhattan Dermatology & Cosmetic Center
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York, Inc.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78705
      • Premier Research
    • College Station, Texas, United States, 77845
      • J & S Studies, Inc.
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research, PA
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle Gel	Drug: CLS001 Topical Gel Vehicle
EXPERIMENTAL: CLS001 topical gel 1%; Topical application once daily	Drug: CLS001 Topical Gel
EXPERIMENTAL: CLS001 topical gel 1.75%; Topical application once daily	Drug: CLS001 Topical Gel
EXPERIMENTAL: CLS001 topical gel 2.5%; Topical application once daily	Drug: CLS001 Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in inflammatory lesion count from Baseline	6, 9 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (ESTIMATE): February 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: CLS001-CO-PR-003