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Treatment of Moderate to Severe Facial Acne Vulgaris

This study is ongoing, but not recruiting participants.
Study NCT00612573.   Last updated on August 20, 2008.   Information provided by Warner Chilcott

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Descriptive Information Fields
Brief Title  Treatment of Moderate to Severe Facial Acne Vulgaris
Official Title  Phase 2 Study Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris
Brief Summary

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Primary efficacy variables will be both the IGA and the absolute change from baseline for inflammatory lesions count at Week 12. [ Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Secondary efficacy variables will be the percent change in inflammatory lesion count and the absolute change from baseline for non-inflammatory and total lesions count at Week 12. [ Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84 ] [ Designated as safety issue: No ]
Condition  Acne Vulgaris
Intervention  Drug: doxycycline
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  280
Start Date  February 2008
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Must be between 12 and 45 years of age.
  • Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

Exclusion Criteria:

  • Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
  • Has a history of pseudomembranous colitis or antibiotic-associated colitis.
  • Has a history of hepatitis or liver damage or renal impairment.
Gender Both
Ages 12 Years to 45 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00612573
Organization ID PR-07907
Secondary IDs †† WC2055
Study Sponsor  Warner Chilcott
Collaborators ††
Investigators 
Study Director:     Angelo Secci, MD     Warner Chilcott    
Information Provided By Warner Chilcott
Verification Date August 2008
First Received Date  January 25, 2008
Last Updated Date August 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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