Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Warner Chilcott

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Doxycycline hyclate

Drug: Doxycycline hyclate (Doryx)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00635609

PR-08607

Details and patient eligibility

About

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.

Full 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.

Enrollment

93 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.