A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)
NCT ID: NCT02608450
Last Updated: 2020-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
708 participants
INTERVENTIONAL
2016-01-21
2018-04-11
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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Gary M. Petrus, MD PA
Little Rock, Arkansas, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
San Diego Sports Medicine and Family Health Center
San Diego, California, United States
Rady Childrens Hospital, Pediatric and Adolescent Dermatology
San Diego, California, United States
Southern California Dermatology
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Memorial Research Medical Clinic dba / Orange County Research Center
Tustin, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Site 0190
Boca Raton, Florida, United States
Study Protocol, Inc.
Boynton Beach, Florida, United States
Site 0196
Miami, Florida, United States
Site 0197
Miami, Florida, United States
Site 0198
Miami, Florida, United States
Site 0199
Miami, Florida, United States
Site 0191
Miami, Florida, United States
Site 0192
Miami, Florida, United States
Site 0195
Miami, Florida, United States
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
MOORE Clinical Research, Inc.
Tampa, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Site 0152
Carmel, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Henry Ford Health System
Detroit, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, United States
DermResearch Center of New York, Inc.
Stony Brook, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
The Pennsylvania State University and the Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Greenville Dermatology, LLC
Greenville, South Carolina, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Westlake Dermatology Clinical Research Center
Austin, Texas, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
J&S Studies, Inc.
College Station, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Site 9911
Tbilisi, , Georgia
Site 9913
Tbilisi, , Georgia
Site 9912
Tbilisi, , Georgia
Site 3802
Dnipro, , Ukraine
Site 3804
Kharkiv, , Ukraine
3808
Kharkiv, , Ukraine
Site 3801
Kyiv, , Ukraine
3807
Lviv, , Ukraine
Site 3803
Ternopil, , Ukraine
Site 3809
Zaporizhzhya, , Ukraine
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-03-01/25
Identifier Type: -
Identifier Source: org_study_id