Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Galderma R&D
Investigator's global assessment and lesion count will be performed at each study visit.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
