Treatment of Moderate to Severe Facial Acne Vulgaris

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Doxycycline 0.6 mg/kg/day
* Drug: Doxycycline 1.2 mg/kg/day
* Drug: Doxycycline 2.4 mg/kg/day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycyline 0.6 mg/kg/day<br>Doxycycline dosed at 40 mg/day to subjects of appropriate weights | Drug: Doxycycline 0.6 mg/kg/day<br>* doxycycline 40 mg/day, oral, 12 weeks<br>|
| Experimental: Doxycycline 1.2 mg/kg/day<br>Doxycycline dosed at 80 mg/day to subjects of appropriate weights | Drug: Doxycycline 1.2 mg/kg/day<br>* doxycycline 80 mg/day, 12 weeks<br>|
| Experimental: Doxycycline 2.4 mg/kg/day<br>Doxycycline dosed at 160 mg/day to subjects of appropriate weights | Drug: Doxycycline 2.4 mg/kg/day<br>* doxycycline 160 mg/day, 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population | Noninflammatory Lesion Count includes open and closed comedones. | 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. | Baseline to Week 12 |