Extension study to evaluate the Safety of CB-03-01 1% cream applied twice daily in subjects with Acne Vulgaris

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

1. Subject must have been enrolled in one of the Phase 3 pivotal studies (CB-03-01/25 and CB-03-01/26), completed the assigned
treatment regimen without any material non-compliance with study requirements or test article dosing (compliance =80%), and
completed the final study visit (Visit 4-Pivotal).
2. Subject agrees to treat his/her facial acne and truncal acne (if designated by investigator AND desired by subject) during the
nine month study period per protocol. Note: Subjects who are clear (IGA=0) at Visit 4-Pivotal are also eligible for this study.
3. Females must be post-menopausal1, surgically sterile2, or using highly effective birth control methods.3,4 Women of
childbearing potential (WOCBP)5 must have a negative urine pregnancy test (UPT) at Visit 4-LTF (or Visit 4-Pivotal, if the visits
occur on the same day).
4. Subject has provided written 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. The parent or legal guardian must
provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written
informed consent at that time to continue study participation.
5. Subject is willing to comply with study instructions and return to the clinic for required visits.
during the study, the subject must provide written informed consent at
that time to continue study participation.
3. Subject has an Investigator’s Global Assessment (IGA) score of 3 or 4 [0
(clear) to 4 (severe) scale].
4. Subject has facial acne vulgaris, which can include the nose, 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 359
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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 safety evaluation of the test products or requires the
use of interfering topical or systemic therapy (see Section 8.1: Prohibited Medications and Therapies).
3. Subject has any condition which, in the investigator’s opinion, would make it unsafe or unsuitable for the subject to participate
in this research study.
4. Subject plans to use any other investigational drug or device during participation in this study.
5. Subject, and parent/guardian if required, is unable to communicate or cooperate with the investigator due to language
problems, poor mental development, or impaired cerebral function.
6. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subject who
is unable to return for scheduled follow-up visits.
7. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test article.
8. Subject is or plans to use any topical anti-acne preparations (excluding CB-03-01 cream) or procedures on the face (or trunk, if
applicable) or any systemic anti-acne medications (as detailed in Section 8.1: Prohibited Medications and Therapies) during the
study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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