A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)
- Conditions
- Acne Vulgaris
- Interventions
- Drug: CB-03-01 cream, 1%Drug: Vehicle cream
- Registration Number
- NCT02608476
- Lead Sponsor
- Cassiopea SpA
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 732
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CB-03-01 cream CB-03-01 cream, 1% CB-03-01 cream, 1% applied twice daily for 12 weeks Vehicle cream Vehicle cream Vehicle cream applied twice daily for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) 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 (NIL) Counts 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 (IL) Counts Baseline and Week 12 Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Total Lesion Counts 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 Counts 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 Counts Baseline and Week 12 Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Change From Baseline in Total Lesion Counts Baseline and Week 12 Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Trial Locations
- Locations (52)
Site 4029
🇷🇴Sector 6, Bucharest, Romania
Site 8138
🇷🇸Belgrade, Serbia
Site 4033
🇷🇴Sector 2, Bucharest, Romania
Site 4030
🇷🇴Sibiu, Romania
Site 8137
🇷🇸Belgrade, Serbia
Site 4034
🇷🇴Sector 2, Bucharest, Romania
Site 9925
🇬🇪Zugdidi, Georgia
Site 8136
🇷🇸Novi Sad, Serbia
Site 4037
🇷🇴Iaşi, Romania
Clear dermatology & Aesthetic Center
🇺🇸Scottsdale, Arizona, United States
Site 4028
🇷🇴Târgovişte, Jud. Dambovita, Romania
Arlington Dermatology
🇺🇸Arlington Heights, Illinois, United States
Skin Specialty Dermatology
🇺🇸New York, New York, United States
Site 4035
🇷🇴Bucharest, Romania
Site 3521
🇧🇬Plovdiv, Bulgaria
Site 4036
🇷🇴Bucarest, Romania
Site 4032
🇷🇴Craiova, Romania
Site 3525
🇧🇬Sofia, Bulgaria
Site 9921
🇬🇪Tbilisi, Georgia
Site 9922
🇬🇪Tbilisi, Georgia
Site 3524
🇧🇬Sofia, Bulgaria
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
Belleair Research Center
🇺🇸Pinellas Park, Florida, United States
Maryland Laser Skin and Vein Institute
🇺🇸Hunt Valley, Maryland, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Sadick Research Group, LLC
🇺🇸New York, New York, United States
3520
🇧🇬Sofia, Bulgaria
Site 3523
🇧🇬Sofia, Bulgaria
Site 3519
🇧🇬Sofia, Bulgaria
Site 3526
🇧🇬Sofia, Bulgaria
Site 9924
🇬🇪Kutaisi, Georgia
Site 9923
🇬🇪Batumi, Georgia
Site 3522
🇧🇬Varna, Bulgaria
Site 9920
🇬🇪Tbilisi, Georgia
4819
🇵🇱Bydgoszcz, Poland
Site 4822
🇵🇱Czestochowa, Poland
Site 4811
🇵🇱Katowice, Poland
Site 4815
🇵🇱Kraków, Poland
Site 4820
🇵🇱Łódź, Poland
Site 4031
🇷🇴Sector 3, Bucharest, Romania
Center for Dermatology and Laser Surgery
🇺🇸Sacramento, California, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
4815
🇵🇱Katowice, Poland
Site 4813
🇵🇱Kraków, Poland
Site 4821
🇵🇱Kraków, Poland
Site 4823
🇵🇱Osielsko, Poland
Site 4816
🇵🇱Rzeszów, Poland
Site 4812
🇵🇱Szczecin, Poland
Site 4818
🇵🇱Warszawa, Poland
Site 4814
🇵🇱Czestochowa, Poland