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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT01320033

Run by

Galderma R&D

People needed

662

Starts

2011-03-29

Expected to finish

2012-01-03

Last updated by the study team

2021-02-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Dermatology Research Associates, Inc. — Los Angeles, California, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Dermatology Specialists PC — Louisville, Kentucky, United States
• Somerset Skin Care Center — Troy, Michigan, United States
• Grekin Skin Care — Warren, Michigan, United States
• Central Dermatology, PC — St Louis, Missouri, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Academic Dermatology — Albuquerque, New Mexico, United States
• Helendale Dermatology & Medical Spa — Rochester, New York, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Haber Dermatology & cosmetic Surgery, Inc — South Euclid, Ohio, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Oregon Dermatology & Research Center — Portland, Oregon, United States
• Stephen Schleicher — Hazleton, Pennsylvania, United States
• Palmetto Clinical Trial Services, LLC — Greenville, South Carolina, United States
• Dermatology Research Associates — Nashville, Tennessee, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Arlington Center for Dermatology — Arlington, Texas, United States
• Derm Research, Inc — Austin, Texas, United States
• J&S Studies — College Station, Texas, United States

Full record on ClinicalTrials.gov

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