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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Doxycylcine hyclate
  • 150mg/day, oral, delayed release tablets
• Drug: Doxycycline hyclate
  • 100 mg/day, oral, tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• 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.
  • Time Frame: Evaluations will be made at weeks 0, 1, 4, 8 and 12.
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: Evaluations will be made at weeks 0, 1, 4, 8 and 12
    Safety Issue?: No
• Tolerability
  • Time Frame: Duration of study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Warner Chilcott

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00635609

Study ID Number: PR-08607

ClinicalTrials.gov Identifier: NCT00635609

Health Authority: United States: Institutional Review Board