Phase 4
N=93
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00635609 ↗Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Dec 2009
Primary outcome: Primary: Successful Outcome According to Investigator's Global Assessment (IGA) — 18; 19 participants — p=0.765
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Doxycycline hyclate (Doryx) (Drug); Doxycycline hyclate (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Warner Chilcott
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Outcome According to Investigator's Global Assessment (IGA) |
18; 19 | 0.765 |
| PRIMARY Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks |
21.8; 26.6 | 0.033 sig |
| SECONDARY Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks |
23.2; 27.6 | 0.290 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00635609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.