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
NCT ID: NCT01320033
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
662 participants
INTERVENTIONAL
2011-03-29
2012-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CD2475/101 40 mg
Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
CD2475/101 40 mg
Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
Placebo
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Doxycycline 100 mg
Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
Doxycycline 100 mg
Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
Placebo
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Placebo
Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
Placebo
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Interventions
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CD2475/101 40 mg
Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
Doxycycline 100 mg
Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
Placebo
Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Graeber, MD
Role: STUDY_DIRECTOR
Galderma R&D
Locations
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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
Suzanne Bruce and associates P.A. The Center for skin Research
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Stephen Miller MD
San Antonio, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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RD.06.SPR.18195
Identifier Type: -
Identifier Source: org_study_id
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