Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635609
• Other study ID #: PR-08607
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2008
• Last updated: April 18, 2012
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: April 2012
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Louisville	Kentucky
United States	Warner Chilcott Investigational Site	Miami	Florida
United States	Warner Chilcott Investigational Site	Rochester	New York
United States	Warner Chilcott Investigational Site	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks	Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.	baseline and 12 weeks	No