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Treatment of Moderate to Severe Facial Acne Vulgaris
This study has been completed.
Study NCT00612573   Information provided by Warner Chilcott
First Received: January 25, 2008   Last Updated: January 27, 2009   History of Changes

January 25, 2008
January 27, 2009
February 2008
November 2008   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00612573 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Treatment of Moderate to Severe Facial Acne Vulgaris
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

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Acne Vulgaris
  • Drug: doxycycline
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
257
December 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612573
Dr. Angelo Secci, Warner Chilcott
PR-07907, WC2055
Warner Chilcott
 
Study Director: Angelo Secci, MD Warner Chilcott
Warner Chilcott
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP