A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)
NCT ID: NCT02608476
Last Updated: 2020-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
732 participants
INTERVENTIONAL
2015-11-16
2018-02-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CB-03-01 cream
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
Vehicle cream
Vehicle cream applied twice daily for 12 weeks
Vehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
Interventions
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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.
Vehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
9 Years
ALL
No
Sponsors
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Cassiopea SpA
INDUSTRY
Responsible Party
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Principal Investigators
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R&D Cassiopea
Role: STUDY_DIRECTOR
Cassiopea S.p.A.
Locations
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Clear dermatology & Aesthetic Center
Scottsdale, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Center for Dermatology and Laser Surgery
Sacramento, California, United States
Belleair Research Center
Pinellas Park, Florida, United States
Arlington Dermatology
Arlington Heights, Illinois, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States
Sadick Research Group, LLC
New York, New York, United States
Skin Specialty Dermatology
New York, New York, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Site 3521
Plovdiv, , Bulgaria
Site 3523
Sofia, , Bulgaria
Site 3525
Sofia, , Bulgaria
3520
Sofia, , Bulgaria
Site 3524
Sofia, , Bulgaria
Site 3519
Sofia, , Bulgaria
Site 3526
Sofia, , Bulgaria
Site 3522
Varna, , Bulgaria
Site 9923
Batumi, , Georgia
Site 9924
Kutaisi, , Georgia
Site 9921
Tbilisi, , Georgia
Site 9920
Tbilisi, , Georgia
Site 9922
Tbilisi, , Georgia
Site 9925
Zugdidi, , Georgia
4819
Bydgoszcz, , Poland
Site 4814
Częstochowa, , Poland
Site 4822
Częstochowa, , Poland
4815
Katowice, , Poland
Site 4811
Katowice, , Poland
Site 4821
Krakow, , Poland
Site 4815
Krakow, , Poland
Site 4813
Krakow, , Poland
Site 4820
Lodz, , Poland
Site 4823
Osielsko, , Poland
Site 4816
Rzeszów, , Poland
Site 4812
Szczecin, , Poland
Site 4818
Warsaw, , Poland
Site 4033
Sector 2, Bucharest, Romania
Site 4034
Sector 2, Bucharest, Romania
Site 4031
Sector 3, Bucharest, Romania
Site 4029
Sector 6, Bucharest, Romania
Site 4028
Târgovişte, Jud. Dambovita, Romania
Site 4036
Bucharest, , Romania
Site 4035
Bucharest, , Romania
Site 4032
Craiova, , Romania
Site 4037
Iași, , Romania
Site 4030
Sibiu, , Romania
Site 8138
Belgrade, , Serbia
Site 8137
Belgrade, , Serbia
Site 8136
Novi Sad, , Serbia
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CB-03-01/26
Identifier Type: -
Identifier Source: org_study_id