Clinical trial NCT02608450: A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)
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: 708
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 Counts
timeFrame: Baseline and Week 12
measure: Change From Baseline in Inflammatory Lesion 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 (NIL) Counts
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Inflammatory Lesion (IL) Counts
timeFrame: Baseline and Week 12
Other outcomes:
measure: Local Site Reactions
timeFrame: Baseline, Weeks 4, 8, and 12
Locations:
city: Little Rock
country: United States
facility: Gary M. Petrus, MD PA
state: Arkansas
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Vitiligo & Pigmentation Institute of Southern California
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine and Family Health Center
state: California
city: San Diego
country: United States
facility: Rady Childrens Hospital, Pediatric and Adolescent Dermatology
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Tustin
country: United States
facility: Memorial Research Medical Clinic dba / Orange County Research Center
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Boca Raton
country: United States
facility: Site 0190
state: Florida
city: Boynton Beach
country: United States
facility: Study Protocol, Inc.
state: Florida
city: Miami
country: United States
facility: Site 0196
state: Florida
city: Miami
country: United States
facility: Site 0197
state: Florida
city: Miami
country: United States
facility: Site 0198
state: Florida
city: Miami
country: United States
facility: Site 0199
state: Florida
city: Miami
country: United States
facility: Site 0191
state: Florida
city: Miami
country: United States
facility: Site 0192
state: Florida
city: Miami
country: United States
facility: Site 0195
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, M.D., P.A.
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Carmel
country: United States
facility: Site 0152
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetic & Laser Surgery
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York, Inc.
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Hershey
country: United States
facility: The Pennsylvania State University and the Milton S. Hershey Medical Center
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Dermatology, LLC
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Tbilisi
country: Georgia
facility: Site 9911
city: Tbilisi
country: Georgia
facility: Site 9913
city: Tbilisi
country: Georgia
facility: Site 9912
city: Dnipro
country: Ukraine
facility: Site 3802
city: Kharkiv
country: Ukraine
facility: Site 3804
city: Kharkiv
country: Ukraine
facility: 3808
city: Kyiv
country: Ukraine
facility: Site 3801
city: Lviv
country: Ukraine
facility: 3807
city: Ternopil'
country: Ukraine
facility: Site 3803
city: Zaporizhzhya
country: Ukraine
facility: Site 3809
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.