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A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

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ClinicalTrials.gov Identifier: NCT02608476
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cassiopea SpA

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE November 16, 2015
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Success rate in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
    Proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
  • Change from baseline in non-inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
  • Change from baseline in inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • Success rate in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
    Proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
  • Change in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
  • Change in inflammatory lesion counts [ Time Frame: Week 12 ]
    Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Change History Complete list of historical versions of study NCT02608476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Change from baseline in total lesion counts [ Time Frame: Baseline and Week 12 ]
    Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
  • Percent change from baseline in total lesion counts [ Time Frame: Baseline and Week 12 ]
    Percent change from Baseline in total lesions counts in each treatment group at Week 12.
  • Percent change from baseline in non-inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
  • Percent change from baseline in inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]
    Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • Change in total lesion counts [ Time Frame: Week 12 ]
    Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
  • Percent change in total lesion counts [ Time Frame: Week 12 ]
    Percent change from Baseline in total lesions counts in each treatment group at Week 12.
  • Percent change in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
  • Percent change in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Current Other Pre-specified Outcome Measures
 (submitted: November 17, 2015)
Local Site Reactions [ Time Frame: Baseline, Weeks 4, 8, and 12 ]
Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
Brief Summary The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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 cream, 1%
    CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
    Other Name: cortexolone 17α-propionate
  • Drug: Vehicle cream
    Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
Study Arms  ICMJE
  • Experimental: CB-03-01 cream
    CB-03-01 cream, 1% applied twice daily for 12 weeks
    Intervention: Drug: CB-03-01 cream, 1%
  • Placebo Comparator: Vehicle cream
    Vehicle cream applied twice daily for 12 weeks
    Intervention: Drug: Vehicle cream
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: February 1, 2019)
732
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
700
Actual Study Completion Date  ICMJE February 21, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
  2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
  3. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].
  4. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
  5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.
  6. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
  3. Subject has greater than two (2) facial nodules.
  4. Subject has nodulocystic acne.
  5. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  6. Subject is currently enrolled in an investigational drug or device study.
  7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
  8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
  9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
  10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
  11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
  12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
  13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
  14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 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 Bulgaria,   Georgia,   Poland,   Romania,   Serbia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608476
Other Study ID Numbers  ICMJE CB-03-01/26
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cassiopea SpA
Study Sponsor  ICMJE Cassiopea SpA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alessandro Mazzetti, MD Cassiopea S.p.A.
PRS Account Cassiopea SpA
Verification Date June 2019

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