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

• Status: Completed
• Trial end date: 2012-01-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Doxycycline

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