Status:
COMPLETED
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Lead Sponsor:
Warner Chilcott
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne ...
Detailed Description
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammator...
Eligibility Criteria
Inclusion
- Must be 12 years of age or older.
- Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00635609
Start Date
March 1 2008
End Date
September 1 2008
Last Update
April 20 2012
Active Locations (4)
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1
Warner Chilcott Investigational Site
Vista, California, United States, 92083
2
Warner Chilcott Investigational Site
Miami, Florida, United States, 33175
3
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40217
4
Warner Chilcott Investigational Site
Rochester, New York, United States, 14623