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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT02066545
First received: February 18, 2014
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: CLS001 Topical Gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cutanea Life Sciences, Inc.:

Primary Outcome Measures:
  • Change in inflammatory lesion count from Baseline [ Time Frame: 6, 9 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of subjects with a 2 grade reduction in the IGA at each visit [ Time Frame: 1, 3, 6, 9, and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: April 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle Gel
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066545

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

No publications provided

Responsible Party: Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier: NCT02066545     History of Changes
Other Study ID Numbers: CLS001-CO-PR-003
Study First Received: February 18, 2014
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on September 18, 2014