Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Doxycycline hyclate (Doryx); Drug: Doxycycline hyclate

• Registration Number: NCT00635609
• Lead Sponsor: Warner Chilcott

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2009-11-23
• Results First Posted: 2009-12-30
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycycline hyclate (Doryx)	Doxycycline hyclate (Doryx)	-
Doxycycline hyclate	Doxycycline hyclate	-

Primary Outcome Measures

Name	Time	Method
Successful Outcome According to Investigator's Global Assessment (IGA)	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks	baseline and 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.

Trial Locations

Locations (1)

Warner Chilcott Investigational Site; 🇺🇸 Rochester, New York, United States