Treatment of Moderate to Severe Facial Acne Vulgaris

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Doxycycline 0.6 mg/kg/day; Drug: Doxycycline 1.2 mg/kg/day; Drug: Doxycycline 2.4 mg/kg/day; Drug: Placebo

• Registration Number: NCT00612573
• Lead Sponsor: Warner Chilcott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study Start: 2008-02
• Study First Posted: 2008-02-11
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Results First Submitted: 2011-02-14
• Results First Submitted QC: 2011-03-18
• Results First Posted: 2011-04-19
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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

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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
Doxycyline 0.6 mg/kg/day	Doxycycline 0.6 mg/kg/day	Doxycycline dosed at 40 mg/day to subjects of appropriate weights
Doxycycline 1.2 mg/kg/day	Doxycycline 1.2 mg/kg/day	Doxycycline dosed at 80 mg/day to subjects of appropriate weights
Doxycycline 2.4 mg/kg/day	Doxycycline 2.4 mg/kg/day	Doxycycline dosed at 160 mg/day to subjects of appropriate weights
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population	Week 12	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.
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population	Baseline to Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population	Baseline to Week 12	Noninflammatory Lesion Count includes open and closed comedones.
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population	Baseline to Week 12	Total Lesion Count is the sum of inflammatory and noninflammatory lesions.

Trial Locations

Locations (1)

Warner Chilcott Investigational Site; 🇺🇸 Spokane, Washington, United States