Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Official Title: “Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Doxycycline hyclate (Doryx)
  • 150mg/day, oral, delayed release tablets
• Drug: Doxycycline hyclate
  • 100 mg/day, oral, tablets, immediate release

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Doxycycline hyclate (Doryx)
• Active Comparator: Doxycycline hyclate

Primary Measures

• Successful Outcome According to Investigator's Global Assessment (IGA)
  • Time Frame: baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
  • Time Frame: baseline and 12 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
  • Time Frame: baseline and 12 weeks
    Safety Issue?: No

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 Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Angelo Secci, MD Study Director Warner Chilcott  

Information obtained from ClinicalTrials.gov on February 12, 2012

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