Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
NCT ID: NCT00688064
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
459 participants
INTERVENTIONAL
2008-08-31
2009-02-28
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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1
Adapalene-BPO + Doxycyline
Adapalene BPO Gel associated with Doxycyline Hyclate
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
2
Vehicle + Doxycycline
Vehicle Gel associated with Doxycycline Hyclate
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Interventions
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Adapalene BPO Gel associated with Doxycyline Hyclate
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Vehicle Gel associated with Doxycycline Hyclate
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with severe facial acne (global severity score of 4)
* Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
* Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Exclusion Criteria
* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
12 Years
35 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Galderma
Principal Investigators
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Linda Stein Gold, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Medical Center-New Center One, Detroit, MI
Locations
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Galderma Investigational Site
Oceanside, California, United States
Galderma Investigational Site
San Diego, California, United States
Galderma Investigational Site
Denver, Colorado, United States
Galderma Investigational Site
Longmont, Colorado, United States
Galderma Investigational Site
Miami, Florida, United States
Galderma Investigational Site
Snellville, Georgia, United States
Galderma Investigational Site
Chicago, Illinois, United States
Galderma Investigational Site
Evansville, Indiana, United States
Galderma Investigational Site
Overland Park, Kansas, United States
Galderma Investigational Site
Louisville, Kentucky, United States
Galderma Investigational Site
Detroit, Michigan, United States
Galderma Investigational Site
Fort Gratiot, Michigan, United States
Galderma Investigational Site
Fridley, Minnesota, United States
Galderma Investigational Site
Omaha, Nebraska, United States
Galderma Investigational Site
Albuquerque, New Mexico, United States
Galderma Investigational Site
Stony Brook, New York, United States
Galderma Investigational Site
Winston-Salem, North Carolina, United States
Galderma Investigational Site
Warren, Ohio, United States
Galderma Investigational Site
Hazleton, Pennsylvania, United States
Galderma Investigational Site
Hershey, Pennsylvania, United States
Galderma Investigational Site
Simpsonville, South Carolina, United States
Galderma Investigational Site
Arlington, Texas, United States
Galderma Investigational Site
Austin, Texas, United States
Galderma Investigational Site
College Station, Texas, United States
Galderma Investigational Site
Houston, Texas, United States
Galderma Investigational Site
Lubbock, Texas, United States
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
Webster, Texas, United States
Galderma Investigational Site
Barrie, Ontario, Canada
Galderma Investigational Site
North Bay, Ontario, Canada
Galderma Investigational Site
Windsor, Ontario, Canada
Galderma Investigational Site
Québec, Quebec, Canada
Galderma Investigational Site
Aibonito, , Puerto Rico
Galderma Investigational Site
Carolina, , Puerto Rico
Countries
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Related Links
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Related Info
Other Identifiers
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RD.03.SPR.29074
Identifier Type: -
Identifier Source: org_study_id
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