Treatment of Moderate to Severe Facial Acne Vulgaris

Warner Chilcott257 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

257

Conditions

Acne Vulgaris

Interventions

Doxycycline 0.6 mg/kg/dayDRUG

doxycycline 40 mg/day, oral, 12 weeks

Doxycycline 1.2 mg/kg/dayDRUG

doxycycline 80 mg/day, 12 weeks

Doxycycline 2.4 mg/kg/dayDRUG

doxycycline 160 mg/day, 12 weeks

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (23)

Warner Chilcott Investigational Site

Encino, California, United States

Outcomes

Primary Outcomes

Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population

IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory \& inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.

Time frame: Week 12

Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population

Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.

Time frame: Baseline to Week 12

Secondary Outcomes

Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population

Noninflammatory Lesion Count includes open and closed comedones.

Time frame: Baseline to Week 12

Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population

Total Lesion Count is the sum of inflammatory and noninflammatory lesions.

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.