Clinical trial NCT02608476: A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: acne
clascoterone
anti-androgen
Lead sponsor: Cassiopea SpA
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 732
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
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.

Primary outcomes:
measure: Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
timeFrame: Week 12
measure: Change From Baseline in Non-inflammatory Lesion (NIL) Counts
timeFrame: Baseline and Week 12
measure: Change From Baseline in Inflammatory Lesion (IL) Counts
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Total Lesion Counts
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Total Lesion Counts
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Non-inflammatory Lesion Counts
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Inflammatory Lesion Counts
timeFrame: Baseline and Week 12
Other outcomes:
measure: Local Site Reactions
timeFrame: Baseline, Weeks 4, 8, and 12
Locations:
city: Scottsdale
country: United States
facility: Clear dermatology & Aesthetic Center
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Pinellas Park
country: United States
facility: Belleair Research Center
state: Florida
city: Arlington Heights
country: United States
facility: Arlington Dermatology
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein Institute
state: Maryland
city: New York
country: United States
facility: Sadick Research Group, LLC
state: New York
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Plovdiv
country: Bulgaria
facility: Site 3521
city: Sofia
country: Bulgaria
facility: Site 3523
city: Sofia
country: Bulgaria
facility: Site 3525
city: Sofia
country: Bulgaria
facility: 3520
city: Sofia
country: Bulgaria
facility: Site 3524
city: Sofia
country: Bulgaria
facility: Site 3519
city: Sofia
country: Bulgaria
facility: Site 3526
city: Varna
country: Bulgaria
facility: Site 3522
city: Batumi
country: Georgia
facility: Site 9923
city: Kutaisi
country: Georgia
facility: Site 9924
city: Tbilisi
country: Georgia
facility: Site 9921
city: Tbilisi
country: Georgia
facility: Site 9920
city: Tbilisi
country: Georgia
facility: Site 9922
city: Zugdidi
country: Georgia
facility: Site 9925
city: Bydgoszcz
country: Poland
facility: 4819
city: Czestochowa
country: Poland
facility: Site 4814
city: Czestochowa
country: Poland
facility: Site 4822
city: Katowice
country: Poland
facility: 4815
city: Katowice
country: Poland
facility: Site 4811
city: Kraków
country: Poland
facility: Site 4821
city: Kraków
country: Poland
facility: Site 4815
city: Kraków
country: Poland
facility: Site 4813
city: Osielsko
country: Poland
facility: Site 4823
city: Rzeszów
country: Poland
facility: Site 4816
city: Szczecin
country: Poland
facility: Site 4812
city: Warszawa
country: Poland
facility: Site 4818
city: Łódź
country: Poland
facility: Site 4820
city: Sector 2
country: Romania
facility: Site 4033
state: Bucharest
city: Sector 2
country: Romania
facility: Site 4034
state: Bucharest
city: Sector 3
country: Romania
facility: Site 4031
state: Bucharest
city: Sector 6
country: Romania
facility: Site 4029
state: Bucharest
city: Târgovişte
country: Romania
facility: Site 4028
state: Jud. Dambovita
city: Bucarest
country: Romania
facility: Site 4036
city: Bucharest
country: Romania
facility: Site 4035
city: Craiova
country: Romania
facility: Site 4032
city: Iaşi
country: Romania
facility: Site 4037
city: Sibiu
country: Romania
facility: Site 4030
city: Belgrade
country: Serbia
facility: Site 8138
city: Belgrade
country: Serbia
facility: Site 8137
city: Novi Sad
country: Serbia
facility: Site 8136
Study officials:
affiliation: Cassiopea S.p.A.
name: R&D Cassiopea
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.