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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Cutanea Life Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT02066545
First received: February 18, 2014
Last updated: May 15, 2014
Last verified: May 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: September 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 Recruiting
Encino, California, United States, 91436
Contact: Chin Koher    818-788-5060    chin@drraoof.com   
Principal Investigator: Joseph Raoof, MD         
Skin Surgery Medical Group, Inc. Recruiting
San Diego, California, United States, 92117
Contact: Traci Gardina    858-292-8641    tgardina@skinsurgerymed.com   
Principal Investigator: Dale Martin, MD         
Clinical Science Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Maria Giles    310-828-8887    mgilescsi@gmail.com   
Principal Investigator: Paul Yamauchi, MD, PhD         
United States, Florida
Skin Care Research, Inc. Recruiting
Boca Raton, Florida, United States, 33486
Contact: Pauline Torres       p.torresscr@comcast.net   
Contact: Angela Garcia       angie.garciascr@comcast.net   
Principal Investigator: Marta Rendon, MD         
Belleair Research Center Recruiting
Pinellas Park, Florida, United States, 33781
Contact: Hue Luong    727-828-3353    huekluong@gmail.com   
Principal Investigator: Gary L Heller, DO         
Moore Clinical Research, Inc. Recruiting
Tampa, Florida, United States, 33609
Contact: Elizabeth Juneja    813-948-7550 ext 402    ejuneja@mooreclinicalresearch.com   
Principal Investigator: Susan Barker         
Kenneth R. Beer, MD, PA Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Monica Dunn, R.N., BSN    561-655-9055    mdunn@palmbeachcosmetic.com   
Principal Investigator: Kenneth R Beer, MD         
United States, Georgia
MedaPhase, Inc. Recruiting
Newnan, Georgia, United States, 30263
Contact: Karen Mangieri, RN    770-252-6900    kmangieri@medaphase.com   
Principal Investigator: Mark Russell Ling, MD, PhD         
United States, Michigan
Hamzavi Dermatology Recruiting
Fort Gratiot, Michigan, United States, 48059
Contact: Jennifer Creasor, RN, CCRC    810-455-1612    jcreasor@hamzavi.com   
Principal Investigator: Fasahat Hamzavi, MD         
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
Contact: Allison Horita    763-571-4200      
Principal Investigator: Steven Kempers, MD         
United States, New Mexico
Academic Dermatology Associates Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Tanya E Salazar    505-247-4220    tsalazar@abqdermtrials.com   
Principal Investigator: Eduardo H Tschen, MD, MBA         
United States, New York
Manhattan Dermatology & Cosmetic Center Recruiting
New York, New York, United States, 10017
Contact: Mussarrat Hussain    201-280-2127    mussarrathussain@gmail.com   
Principal Investigator: Dendy Engelman, MD         
Derm Research Center of New York, Inc. Recruiting
Stony Brook, New York, United States, 11790
Contact: Caroline Hennessy, LPN    631-689-1900    chennessy@drcny.com   
Principal Investigator: Elyse Rafal, MD         
United States, North Carolina
Dermatology Consulting Services Recruiting
High Point, North Carolina, United States, 27262
Contact: Vickie Ellis    336-841-2040    dcs3@northstate.net   
Principal Investigator: Zoe Diana Draelos, MD         
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Brandi Ritter    919-781-2514    britter@wakeresearch.com   
Principal Investigator: Adnan Nasir, MD         
United States, Tennessee
Tennessee Clinical Research Center Recruiting
Nashville, Tennessee, United States, 37215
Contact: Brynne Thompson    615-383-9660    bthompson@tnclinicalresearch.com   
Principal Investigator: Michael H Gold, MD         
United States, Texas
Premier Research Recruiting
Austin, Texas, United States, 78705
Contact: Alicia Bauman, RN, BSN    512-287-6321    alicia.bauman@premier-research.com   
Principal Investigator: Dayna Diven, MD         
J & S Studies, Inc. Recruiting
College Station, Texas, United States, 77845
Contact: Jeremy Scott    979-774-5933    jscott@js-studies.com   
Principal Investigator: Terry M Jones, MD         
Progressive Clinical Research, PA Recruiting
San Antonio, Texas, United States, 78229
Contact: Estella Marquez, LVN    210-614-5557    emarquez@progclin.com   
Principal Investigator: Mark Lee, MD         
United States, Washington
Premier Clinical Research Recruiting
Spokane, Washington, United States, 99204
Contact: Kathy Bland    509-343-3710    research@premierclinicalresearch.com   
Principal Investigator: William Werschler, MD         
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: May 15, 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 July 23, 2014