A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intrepid Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01631474
First received: June 27, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.


Condition Intervention Phase
Acne Vulgaris
Drug: CB-03-01
Drug: Vehicle
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, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Intrepid Therapeutics, Inc.:

Primary Outcome Measures:
  • Investigator's Global Assessment (IGA) "Success" - Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.

  • Inflammatory and Non-Inflammatory Lesion Counts - Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.


Secondary Outcome Measures:
  • Inflammatory and Non-Inflammatory Lesion Counts - Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.

  • Total Lesion Counts - Weeks 8 and 12 [ Time Frame: Baseline, Week 8 and Week 12 ] [ Designated as safety issue: No ]
    Percent change from Baseline in lesion counts in each treatment group at Weeks 8 and 12.

  • IGA "Success" - Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    Proportion of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).

  • IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12 [ Time Frame: Baseline, Week 4, Week 8 and Week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.


Enrollment: 363
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-dose active, BID
low dose of CB-03-01, applied twice a day
Drug: CB-03-01
Topical cream, applied twice a day
Experimental: Medium-dose active, BID
medium dose of CB-03-01, applied twice a day
Drug: CB-03-01
Topical cream, applied twice a day
Experimental: High-dose active, QD
high dose of CB-03-01, applied once a day
Drug: CB-03-01
Topical cream, applied once a day
Experimental: High-dose active, BID
high dose of CB-03-01, applied twice a day
Drug: CB-03-01
Topical cream, applied twice a day
Placebo Comparator: Vehicle, QD or BID
vehicle cream, applied once or twice a day
Drug: Vehicle
Topical cream, applied once or twice a day

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
  • Subject has provided written and verbal informed consent/assent.
  • Subject has facial acne vulgaris (including the nose).
  • Subject is willing to comply with study instructions and return to the clinic for required visits.
  • Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

  • Subject is pregnant, lactating, or is planning to become pregnant during the study.
  • Subject is currently enrolled in an investigational drug or device study.
  • Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
  • Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial
  • Subject has used any of the following topical anti-acne preparations or procedures on the face:

    • Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
    • Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
    • Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.
  • Subject has used the following systemic anti-acne medications:

    • Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
    • Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
    • Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
    • Retinoid therapy within six months of the initiation of treatment.
  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: NCT01631474

Locations
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Therapeutics Clinical Research
San Diego, California, United States, 92123
University Clinical Trials
San Diego, California, United States, 92123
United States, Florida
International Clinical Research - US, LLC
Sanford, Florida, United States
United States, Georgia
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States, 30078
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, New York
Marina I. Peredo, M.D., PC
Smithtown, New York, United States
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center - Dept. of Dermatology
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States
United States, Texas
J & S Studies
College Station, Texas, United States, 77845
UT Houston Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Intrepid Therapeutics, Inc.
Investigators
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Intrepid Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01631474     History of Changes
Other Study ID Numbers: 171-7151-201
Study First Received: June 27, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Intrepid Therapeutics, Inc.:
Intrepid
acne
antiandrogen

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

ClinicalTrials.gov processed this record on August 18, 2014