Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
1 other identifier
interventional
93
1 country
4
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 vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2008
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
December 30, 2009
CompletedApril 20, 2012
April 1, 2012
6 months
March 7, 2008
September 23, 2009
April 18, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Successful Outcome According to Investigator's Global Assessment (IGA)
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
baseline and 12 weeks
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
baseline and 12 weeks
Secondary Outcomes (1)
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
baseline and 12 weeks
Study Arms (2)
Doxycycline hyclate (Doryx)
EXPERIMENTALDoxycycline hyclate
ACTIVE COMPARATORInterventions
150mg/day, oral, delayed release tablets
Eligibility Criteria
You may qualify if:
- Must be 12 years of age or older.
- Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (4)
Warner Chilcott Investigational Site
Vista, California, 92083, United States
Warner Chilcott Investigational Site
Miami, Florida, 33175, United States
Warner Chilcott Investigational Site
Louisville, Kentucky, 40217, United States
Warner Chilcott Investigational Site
Rochester, New York, 14623, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grexan Wulff, Manager Regulatory Affairs
- Organization
- Warner Chilcott
Study Officials
- STUDY DIRECTOR
Angelo Secci, MD
Warner Chilcott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 14, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
April 20, 2012
Results First Posted
December 30, 2009
Record last verified: 2012-04