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

NCT02608476 | Completed Phase 3 Results

• 1 other identifier: CB-03-01/26
• Study Type: interventional
• Target: 732
• Locations: 6 countries
• Sites: 52

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.

Conditions

Acne Vulgaris

Keywords

acne; clascoterone; anti-androgen

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)

  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.

  Week 12

• Change From Baseline in Non-inflammatory Lesion (NIL) Counts

  Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.

  Baseline and Week 12

• Change From Baseline in Inflammatory Lesion (IL) Counts

  Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.

  Baseline and Week 12

Secondary Outcomes (4)

• Change From Baseline in Total Lesion Counts

  Baseline and Week 12

• Percent Change From Baseline in Total Lesion Counts

  Baseline and Week 12

• Percent Change From Baseline in Non-inflammatory Lesion Counts

  Baseline and Week 12

• Percent Change From Baseline in Inflammatory Lesion Counts

  Baseline and Week 12

Other Outcomes (1)

• Local Site Reactions

  Baseline, Weeks 4, 8, and 12

Study Arms (2)

CB-03-01 cream

EXPERIMENTAL

CB-03-01 cream, 1% applied twice daily for 12 weeks

Drug: CB-03-01 cream, 1%

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream applied twice daily for 12 weeks

Drug: Vehicle cream

Interventions

CB-03-01 cream, 1% DRUG

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.

Also known as: cortexolone 17α-propionate, clascoterone (USAN, INN)

CB-03-01 cream

Vehicle cream DRUG

Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.

Vehicle cream

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) \[0 (clear) to 4 (severe) scale\].
• 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).
• Subject and parent/guardian (if applicable) are 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 (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.

You may not qualify if:

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• 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.
• Subject has greater than two (2) facial nodules.
• Subject has nodulocystic acne.
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
• Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
• 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.
• 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.
• Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
• 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 prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
• Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

Sponsors & Collaborators

• Cassiopea SpA: lead

Study Sites (52)

Clear dermatology & Aesthetic Center

Scottsdale, Arizona, 85255, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Belleair Research Center

Pinellas Park, Florida, 33781, United States

Location

Arlington Dermatology

Arlington Heights, Illinois, 60005, United States

Location

Kansas City Dermatology, PA

Overland Park, Kansas, 66215, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Sadick Research Group, LLC

New York, New York, 10075, United States

Location

Skin Specialty Dermatology

New York, New York, 10155, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78229, United States

Location

Site 3521

Plovdiv, 4000, Bulgaria

Location

Site 3523

Sofia, 1000, Bulgaria

Location

Site 3525

Sofia, 1404, Bulgaria

Location

3520

Sofia, 1407, Bulgaria

Location

Site 3524

Sofia, 1407, Bulgaria

Location

Site 3519

Sofia, 1431, Bulgaria

Location

Site 3526

Sofia, 1618, Bulgaria

Location

Site 3522

Varna, 9010, Bulgaria

Location

Site 9923

Batumi, 6010, Georgia

Location

Site 9924

Kutaisi, 4600, Georgia

Location

Site 9921

Tbilisi, 0145, Georgia

Location

Site 9920

Tbilisi, 0177, Georgia

Location

Site 9922

Tbilisi, 0186, Georgia

Location

Site 9925

Zugdidi, 2100, Georgia

Location

4819

Bydgoszcz, 85-863, Poland

Location

Site 4814

Częstochowa, 15-794, Poland

Location

Site 4822

Częstochowa, 42-217, Poland

Location

4815

Katowice, 40-611, Poland

Location

Site 4811

Katowice, 62-069, Poland

Location

Site 4821

Krakow, 30-002, Poland

Location

Site 4815

Krakow, 40-611, Poland

Location

Site 4813

Krakow, 70-332, Poland

Location

Site 4820

Lodz, 91-334, Poland

Location

Site 4823

Osielsko, 86-031, Poland

Location

Site 4816

Rzeszów, 61-113, Poland

Location

Site 4812

Szczecin, 51-685, Poland

Location

Site 4818

Warsaw, 02-106, Poland

Location

Site 4033

Sector 2, Bucharest, 020125, Romania

Location

Site 4034

Sector 2, Bucharest, 020125, Romania

Location

Site 4031

Sector 3, Bucharest, 030303, Romania

Location

Site 4029

Sector 6, Bucharest, 062272, Romania

Location

Site 4028

Târgovişte, Jud. Dambovita, Romania

Location

Site 4036

Bucharest, 010825, Romania

Location

Site 4035

Bucharest, 011025, Romania

Location

Site 4032

Craiova, 200642, Romania

Location

Site 4037

Iași, 700381, Romania

Location

Site 4030

Sibiu, 550245, Romania

Location

Site 8138

Belgrade, 11050, Serbia

Location

Site 8137

Belgrade, 8137, Serbia

Location

Site 8136

Novi Sad, 21000, Serbia

Location

Related Publications (3)

• Hebert A, Eichenfield L, Thiboutot D, Stein Gold L, Vassileva S, Mihaylova Y, Cartwright M, Moro L, Fragasso E, Han J, Squittieri N, Mazzetti A. Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.

  PMID: 36745367 DERIVED

• 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.

  PMID: 34607697 DERIVED

• 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.

  PMID: 32320027 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Cassiopea R&D
• Organization: Cassiopea, SPA

r&d@cassiopea.com

+39 02 868 911 24

Study Officials

• R&D Cassiopea

  Cassiopea S.p.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 18, 2015
• Study Start: November 16, 2015
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Locations

SE (3); GE (6); PL (13); RO (10); BU (8); US (12)