Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Warner Chilcott93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

Doxycycline hyclate (Doryx)DRUG

150mg/day, oral, delayed release tablets

Doxycycline hyclateDRUG

100 mg/day, oral, tablets, immediate release

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (4)

Warner Chilcott Investigational Site

Vista, California, United States

Warner Chilcott Investigational Site

Miami, Florida, United States

Warner Chilcott Investigational Site

Louisville, Kentucky, United States

Warner Chilcott Investigational Site

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and 12 weeks

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.

Time frame: baseline and 12 weeks

Secondary Outcomes

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.

Time frame: baseline and 12 weeks

Data from ClinicalTrials.gov

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