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

Launched by CASSIOPEA SPA · Nov 17, 2015

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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.