A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: CB-03-01 cream, 1%
Drug: Vehicle cream

Registration Number: NCT02608450

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: 708

Inclusion Criteria

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.

Exclusion Criteria

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
Change From Baseline in Inflammatory Lesion Counts	Baseline and Week 12	Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Change From Baseline in Non-inflammatory Lesion Counts	Baseline and Week 12	Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts	Baseline and Week 12	Percent change from Baseline in non-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.
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 Inflammatory Lesion (IL) Counts	Baseline and Week 12	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.

Trial Locations

Locations (54): 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
Site 0196
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Miami, Florida, United States
Site 0198
🇺🇸
Miami, Florida, United States
Site 0199
🇺🇸
Miami, Florida, United States
Site 0192
🇺🇸
Miami, Florida, United States
Site 0195
🇺🇸
Miami, Florida, United States
The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
Dermatology Associates
🇺🇸
Seattle, Washington, United States
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
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
Memorial Research Medical Clinic dba / Orange County Research Center
🇺🇸
Tustin, California, United States
Study Protocol, Inc.
🇺🇸
Boynton Beach, Florida, United States
Site 0190
🇺🇸
Boca Raton, Florida, United States
Site 0197
🇺🇸
Miami, Florida, United States
Site 0191
🇺🇸
Miami, Florida, United States
Tory Sullivan, M.D., P.A.
🇺🇸
North Miami Beach, Florida, United States
Meridien Research
🇺🇸
Saint Petersburg, Florida, United States
MedaPhase, Inc.
🇺🇸
Newnan, Georgia, United States
Site 0152
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Carmel, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸
Plainfield, Indiana, United States
The Center for Dermatology, Cosmetic & Laser Surgery
🇺🇸
Mount Kisco, New York, United States
MediSearch Clinical Trials
🇺🇸
Saint Joseph, Missouri, United States
DermResearch Center of New York, Inc.
🇺🇸
Stony Brook, New York, 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
Bellaire Dermatology Associates
🇺🇸
Bellaire, Texas, United States
J&S Studies, Inc.
🇺🇸
College Station, Texas, United States
Austin Institute for Clinical Research, Inc.
🇺🇸
Pflugerville, Texas, United States
Clinical Research Associates of Tidewater, Inc.
🇺🇸
Norfolk, Virginia, United States
Site 9911
🇬🇪
Tbilisi, Georgia
Site 9912
🇬🇪
Tbilisi, Georgia
Site 3801
🇺🇦
Kyiv, Ukraine
3807
🇺🇦
Lviv, Ukraine
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
Site 9913
🇬🇪
Tbilisi, Georgia
Site 3804
🇺🇦
Kharkiv, Ukraine
Site 3802
🇺🇦
Dnipro, Ukraine
3808
🇺🇦
Kharkiv, Ukraine
Site 3803
🇺🇦
Ternopil', Ukraine
Site 3809
🇺🇦
Zaporizhzhya, Ukraine
Southern California Dermatology
🇺🇸
Santa Ana, California, United States
Wake Research Associates
🇺🇸
Raleigh, North Carolina, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Westlake Dermatology Clinical Research Center
🇺🇸
Austin, Texas, United States
Horizons Clinical Research Center, LLC
🇺🇸
Denver, Colorado, United States
MOORE Clinical Research, Inc.
🇺🇸
Tampa, Florida, United States