Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Information source: Warner Chilcott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Doxycylcine hyclate (Drug); Doxycycline hyclate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Warner Chilcott Overall contact:
Lara Cardinali, Phone: 973-442-3285, Email: lcardinali@wcrx.com
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 vulgaris.
Clinical Details
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Primary efficacy variables will be both the dichotomized IGA score; where "success" is defined as at least a two grade decrease from baseline on the rating scale at Week 12; and the absolute change from baseline for inflammatory lesions count at Week 12.
Secondary outcome: The secondary efficacy variable will be the percent change in inflammatory lesion count and the absolute change from baseline for non-inflammatory lesion count at Week 12.Tolerability
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 in
inflammatory lesion count in patients with moderate to severe facial acne vulgaris.
Additionally, the absolute change from baseline in non-inflammatory lesions count of Doryx
Delayed Release Tablets compared to doxycycline hyclate will be evaluated.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 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.
Locations and Contacts
Lara Cardinali, Phone: 973-442-3285, Email: lcardinali@wcrx.com
Warner Chilcott Investigational Site, Vista, California 92083, United States; Recruiting
Warner Chilcott Investigational Site, Miami, Florida, United States; Recruiting
Warner Chilcott Investigational Site, Louisville, Kentucky, United States; Recruiting
Warner Chilcott Investigational Site, Rochester, New York, United States; Recruiting
Additional Information
Starting date: March 2008
Last updated: June 18, 2008
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