A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID: NCT02608476
Run by: Cassiopea SpA
People needed: 732
Starts: 2015-11-16
Expected to finish: 2018-02-21
Last updated by the study team: 2020-11-20

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Johnson Dermatology — Fort Smith, Arkansas, United States
Center for Dermatology and Laser Surgery — Sacramento, California, United States
Belleair Research Center — Pinellas Park, Florida, United States
Arlington Dermatology — Arlington Heights, Illinois, United States
Kansas City Dermatology, PA — Overland Park, Kansas, United States
Maryland Laser Skin and Vein Institute — Hunt Valley, Maryland, United States
Sadick Research Group, LLC — New York, New York, United States
Skin Specialty Dermatology — New York, New York, United States
Clinical Partners, LLC — Johnston, Rhode Island, United States
Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
Progressive Clinical Research, PA — San Antonio, Texas, United States
Site 3521 — Plovdiv, Bulgaria
Site 3523 — Sofia, Bulgaria
Site 3525 — Sofia, Bulgaria
3520 — Sofia, Bulgaria
Site 3524 — Sofia, Bulgaria
Site 3519 — Sofia, Bulgaria
Site 3526 — Sofia, Bulgaria
Site 3522 — Varna, Bulgaria
Site 9923 — Batumi, Georgia
Site 9924 — Kutaisi, Georgia
Site 9921 — Tbilisi, Georgia
Site 9920 — Tbilisi, Georgia
Site 9922 — Tbilisi, Georgia
Clear dermatology & Aesthetic Center — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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