Treatment of Moderate to Severe Facial Acne Vulgaris

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Doxycycline 1.2 mg/kg/day; Drug: Doxycycline 2.4 mg/kg/day; Drug: Doxycycline 0.6 mg/kg/day; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612573

WC2055

PR-07907

Details and patient eligibility

About

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Enrollment: 257 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be between 12 and 45 years of age.
• Has a diagnosis of moderate to severe 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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257 participants in 4 patient groups, including a placebo group

Doxycyline 0.6 mg/kg/day

Experimental group

Description:

Doxycycline dosed at 40 mg/day to subjects of appropriate weights

Treatment:

Drug: Doxycycline 0.6 mg/kg/day

Doxycycline 1.2 mg/kg/day

Experimental group

Description:

Doxycycline dosed at 80 mg/day to subjects of appropriate weights

Treatment:

Drug: Doxycycline 1.2 mg/kg/day

Doxycycline 2.4 mg/kg/day

Experimental group

Description:

Doxycycline dosed at 160 mg/day to subjects of appropriate weights

Treatment:

Drug: Doxycycline 2.4 mg/kg/day

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo