Facial and truncal acne vulgaris MedDRA version: 19.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Sponsors
CASSIOPEA SpA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in subjects with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.;Secondary Objective: na; Primary end point(s): •Incidence of any local and systemic treatment emergent AEs (TEAEs). •Number of subjects with presence (and severity) of each individual LSR (Local Skin Reaction) (telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus) for each treatment area, as applicable, at each time point collected (Baseline, and LTF-Months 1, 3, 6, and 9, and any Unscheduled Visits). •UPT results in all WOCBP at Baseline, LTF-Month 6, and EOS. ;Timepoint(s) of evaluation of this end point: during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of subjects with each IGA (Investigator’s Global Assessment, IGA) severity score for each treatment area, as applicable, at each time point collected;Timepoint(s) of evaluation of this end point: Baseline and LTF-Months 1, 3, 6, and 9 | — |
Countries
Bulgaria, Poland, Serbia, United States
Contacts
Public ContactCassiopea Research & Development
CASSIOPEA SpA
Outcome results
None listed