Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Doxycycline hyclate (Doryx)
* Drug: Doxycycline hyclate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycycline hyclate (Doryx)<br> | Drug: Doxycycline hyclate (Doryx)<br>* 150mg/day, oral, delayed release tablets<br>* Other names: Doryx;|
| Active Comparator: Doxycycline hyclate<br> | Drug: Doxycycline hyclate<br>* 100 mg/day, oral, tablets, immediate release<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 12 weeks |