Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
NCT ID: NCT01628549
Last Updated: 2019-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
285 participants
INTERVENTIONAL
2012-06-30
2013-01-31
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
DOUBLE
Study Groups
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P005672-HCl approximately 0.75 mg/kg/day
One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
P005672-HCl approximately 1.5 mg/kg/day
Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
P005672-HCl approximately 3.0 mg/kg/day
Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
100 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Placebo
Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
Interventions
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50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
100 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
* Male or female, 12-45 years of age with body weight between 52 and 88 kg
* Diagnosis of acne vulgaris with:
20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)
* No more than 2 nodules on the face
* Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)
Exclusion Criteria
Within 1 week prior to randomization:
* Medicated facial cleansers
* Topical acne treatments (other than those listed below)
Within 4 weeks prior to randomization:
* Topical retinoids
* Topical anti-inflammatories and corticosteroids
* Systemic antibiotics
* Systemic acne treatments
Within 12 weeks prior to randomization:
* Systemic retinoids
* Systemic corticosteroids
* Pseudomembranous colitis or antibiotic-associated colitis
* Hepatitis, liver damage or renal impairment
12 Years
45 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Herman Ellman, MD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
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Warner Chilcott Investigational Site
Mobile, Alabama, United States
Warner Chilcott Investigational Site
Tucson, Arizona, United States
Warner Chilcott Investigational Site
Hot Springs, Arkansas, United States
Warner Chilcott Investigational Site
Los Angeles, California, United States
Warner Chilcott Investigational Site
San Diego, California, United States
Warner Chilcott Investigational Site
Santa Monica, California, United States
Warner Chilcott Investigational Site
Clearwater, Florida, United States
Warner Chilcott Investigational Site
Coral Gables, Florida, United States
Warner Chilcott Investigational Site
Gainesville, Florida, United States
Warner Chilcott Investigational Site
Miami, Florida, United States
Warner Chilcott Investigational Site
Miramar, Florida, United States
Warner Chilcott Investigational Site
Pinellas Park, Florida, United States
Warner Chilcott Investigational Site
Arlington Heights, Illinois, United States
Warner Chilcott Investigational Site
Chicago, Illinois, United States
Warner Chilcott Investigational Site
Granger, Indiana, United States
Warner Chilcott Investigational Site
Indianapolis, Indiana, United States
Warner Chilcott Investigational Site
Louisville, Kentucky, United States
Warner Chilcott Investigational Site
Boston, Massachusetts, United States
Warner Chilcott Investigational Site
Fridley, Minnesota, United States
Warner Chilcott Investigational Site
St Louis, Missouri, United States
Warner Chilcott Investigational Site
Berlin, New Jersey, United States
Warner Chilcott Investigational Site
Albuquerque, New Mexico, United States
Warner Chilcott Investigational Site
Rochester, New York, United States
Warner Chilcott Investigational Site
Rochester, New York, United States
Warner Chilcott Investigational Site
Charlotte, North Carolina, United States
Warner Chilcott Investigational Site
Salisbury, North Carolina, United States
Warner Chilcott Investigational Site
Wilmington, North Carolina, United States
Warner Chilcott Investigational Site
Cincinnati, Ohio, United States
Warner Chilcott Investigational Site
Portland, Oregon, United States
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, United States
Warner Chilcott Investigational Site
Greer, South Carolina, United States
Warner Chilcott Investigational Site
Arlington, Texas, United States
Warner Chilcott Investigational Site
Austin, Texas, United States
Warner Chilcott Investigational Site
Houston, Texas, United States
Warner Chilcott Investigational Site
Plano, Texas, United States
Warner Chilcott Investigational Site
San Antonio, Texas, United States
Warner Chilcott Investigational Site
Sandy City, Utah, United States
Warner Chilcott Investigational Site
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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PR-10411
Identifier Type: -
Identifier Source: org_study_id
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