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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631474
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Intrepid Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 27, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date April 16, 2015
Study Start Date  ICMJE June 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Investigator's Global Assessment (IGA) "Success" - Week 12 [ Time Frame: Baseline and Week 12 ]
    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 ]
    Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Inflammatory and Non-Inflammatory Lesion Counts - Week 8 [ Time Frame: Baseline and Week 8 ]
    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 ]
    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 ]
    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 ]
    Proportion of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: CB-03-01
    Topical cream, applied once a day
  • Drug: Vehicle
    Topical cream, applied once or twice a day
  • Drug: CB-03-01
    Topical cream, applied twice a day
Study Arms  ICMJE
  • Experimental: Low-dose active, BID
    low dose of CB-03-01, applied twice a day
    Intervention: Drug: CB-03-01
  • Experimental: Medium-dose active, BID
    medium dose of CB-03-01, applied twice a day
    Intervention: Drug: CB-03-01
  • Experimental: High-dose active, QD
    high dose of CB-03-01, applied once a day
    Intervention: Drug: CB-03-01
  • Experimental: High-dose active, BID
    high dose of CB-03-01, applied twice a day
    Intervention: Drug: CB-03-01
  • Placebo Comparator: Vehicle, QD or BID
    vehicle cream, applied once or twice a day
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2014)
363
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
360
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631474
Other Study ID Numbers  ICMJE 171-7151-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intrepid Therapeutics, Inc.
Study Sponsor  ICMJE Intrepid Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
PRS Account Intrepid Therapeutics, Inc.
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP