Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01320033
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects 12 years of age or older
* acne vulgaris with facial involvement
* A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)
* 25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)
Exclusion Criteria:
* More than two acne nodules/cysts on the face
* Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment
* Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea
* Beard or facial hair which might interfere with study assessments
* planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)
* Use of oral contraceptives solely for control of acne
* Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal
* Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher
* Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis
* Females who intend to conceive a child within 5 months following Baseline visit
* Males who intend to conceive a child with partner during the study period
* Requiring concomitant use of methoxyflurane
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01320033
Study Brief:
Protocol Section:
NCT01320033