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

Galderma

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: Doxycycline 100 mg; Drug: CD2475/101 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01320033

RD.06.SPR.18195

Details and patient eligibility

About

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.

Full description

Investigator's global assessment and lesion count will be performed at each study visit.

Enrollment: 662 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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662 participants in 3 patient groups, including a placebo group

CD2475/101 40 mg

Experimental group

Description:

Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.

Treatment:

Drug: Placebo

Drug: CD2475/101 40 mg

Doxycycline 100 mg

Active Comparator group

Description:

Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.

Treatment:

Drug: Placebo

Drug: Doxycycline 100 mg

Placebo

Placebo Comparator group

Description:

Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.

Treatment:

Drug: Placebo