An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
NCT ID: NCT02682264
Last Updated: 2020-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
609 participants
INTERVENTIONAL
2016-03-09
2018-08-31
Brief Summary
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Detailed Description
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Participants treated facial acne per protocol for nine months. Treatment of truncal acne was discussed by the investigator and participant. Treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk).
Participants were rolled over from the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CB-03-01 cream, 1%
CB-03-01 (cortexolone 17α-propionate) Cream, 1%, applied twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
CB-03-01 cream, 1%
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Interventions
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CB-03-01 cream, 1%
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant agrees to use effective method of contraception throughout study, if applicable.
* Participant has provided written informed consent or assent.
* Participant is willing to comply with study instructions and return to the clinic for required visits.
Exclusion Criteria
* Participant has any skin disease or condition that could interfere with the safety evaluation of the test products or requires the use of interfering topical or systemic therapy.
* Participant has any condition which, in the investigator's opinion, would make it unsafe or unsuitable for the participant to participate in this research study.
* Participant plans to use any other investigational drug or device during participation in this study.
* Participant has known hypersensitivity or previous allergic reaction to the drug or any of its ingredients.
* Participant is or plans to use any restricted systemic and/or topical anti-acne preparations or medications during the study
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 SpA
Locations
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Johnson Dermatology
Fort Smith, Arkansas, United States
Gary M. Petrus, MD PA
Little Rock, Arkansas, United States
Center for Dermatology and Laser Surgery
Sacramento, 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
Study Protocol, Inc.
Boynton Beach, Florida, United States
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, United States
Belleair Research Center
Pinellas Park, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
MOORE Clinical Research, Inc.
Tampa, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Arlington Dermatology
Arlington Heights, Illinois, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Sadick Research Group, LLC
New York, New York, United States
Skin Specialty Dermatology
New York, New York, United States
DermResearch Center of New York, Inc.
Stony Brook, New York, 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
Clinical Partners, LLC
Johnston, Rhode Island, 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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, 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 3521
Plovdiv, , Bulgaria
3520
Sofia, , Bulgaria
Site 3524
Sofia, , Bulgaria
Site 3519
Sofia, , Bulgaria
Site 3526
Sofia, , Bulgaria
Site 3522
Varna, , Bulgaria
Site 9912
Tbilisi, , Georgia
Site 9911
Tbilisi, , Georgia
Site 9913
Tbilisi, , Georgia
Site 4814
Bialystok, , Poland
4819
Bydgoszcz, , Poland
Site 4822
Częstochowa, , Poland
Site 4811
Dąbrówka, , Poland
4815
Katowice, , Poland
Site 4821
Krakow, , Poland
Site 4820
Lodz, , Poland
Site 4823
Osielsko, , Poland
Site 4813
Szczecin, , Poland
Site 4818
Warsaw, , Poland
Site 4812
Wroclaw, , 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 4035
Bucharest, , Romania
Site 4037
Iași, , Romania
Site 4030
Sibiu, , Romania
Site 8138
Belgrade, , Serbia
Site 8137
Belgrade, , Serbia
Site 8136
Novi Sad, , Serbia
Site 3802
Dnipro, , Ukraine
Site 3808
Kharkiv, , Ukraine
Site 3804
Kharkiv, , Ukraine
Site 3809
Zaporizhzhya, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CB-03-01/27
Identifier Type: -
Identifier Source: org_study_id