Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
Overview
- Phase
- Phase 4
- Intervention
- Doxycycline hyclate (Doryx)
- Conditions
- Acne Vulgaris
- Sponsor
- Warner Chilcott
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Successful Outcome According to Investigator's Global Assessment (IGA)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
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 inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.
Investigators
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.
Arms & Interventions
Doxycycline hyclate (Doryx)
Intervention: Doxycycline hyclate (Doryx)
Doxycycline hyclate
Intervention: Doxycycline hyclate
Outcomes
Primary Outcomes
Successful Outcome According to Investigator's Global Assessment (IGA)
Time Frame: baseline and 12 weeks
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.
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Time Frame: baseline and 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.
Secondary Outcomes
- Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks(baseline and 12 weeks)