A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

• ClinicalTrials.gov Identifier: NCT02608450
• Recruitment Status: Completed
• First Posted: November 18, 2015
• Results First Posted: November 20, 2020
• Last Update Posted: November 20, 2020
• Sponsor: Cassiopea SpA
• Information provided by (Responsible Party): Cassiopea SpA

Tracking Information

• First Submitted Date: November 17, 2015
• First Posted Date: November 18, 2015
• Results First Submitted Date: September 23, 2020
• Results First Posted Date: November 20, 2020
• Last Update Posted Date: November 20, 2020
• Actual Study Start Date: January 21, 2016
• Actual Primary Completion Date: April 11, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 29, 2020)

• Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
  Percentage 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 (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.

Current Secondary Outcome Measures (submitted: October 29, 2020)

• 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 (NIL) 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 (IL) 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 (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: A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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 Names:

  • cortexolone 17α-propionate
  • clascoterone (USAN, INN)
• 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

• 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 *

• Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.
• Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2019): 708
• Original Estimated Enrollment (submitted: November 17, 2015): 700
• Actual Study Completion Date: April 11, 2018
• Actual Primary Completion Date: April 11, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 9 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Georgia, Ukraine, United States

Administrative Information

• NCT Number: NCT02608450
• Other Study ID Numbers: CB-03-01/25
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Cassiopea SpA
• Original Responsible Party: Same as current
• Current Study Sponsor: Cassiopea SpA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: R&D Cassiopea; Cassiopea S.p.A.

• PRS Account: Cassiopea SpA
• Verification Date: October 2020