Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Official Title
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A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: 50 mg P005672-HCl
* Drug: Placebo
* Drug: 100 mg P005672-HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: if women of child-bearing potential, have a negative urine pregnancy test Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study Male or female, 12-45 years of age with body weight between 52 and 88 kg Diagnosis of acne vulgaris with: 20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones) No more than 2 nodules on the face Investigator's Global Assessment (IGA) score of moderate (3) to severe (4) Exclusion Criteria: Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible: Within 1 week prior to randomization: Medicated facial cleansers Topical acne treatments (other than those listed below) Within 4 weeks prior to randomization: Topical retinoids Topical anti-inflammatories and corticosteroids Systemic antibiotics Systemic acne treatments Within 12 weeks prior to randomization: Systemic retinoids Systemic corticosteroids Pseudomembranous colitis or antibiotic-associated colitis Hepatitis, 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P005672-HCl approximately 0.75 mg/kg/day<br>One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks | Drug: 50 mg P005672-HCl<br>* P005672-HCl administered as an oral capsule(s) once daily<br>* Other names: WC3035, Sarecycline;Drug: Placebo<br>* Dose-matched Placebo capsule administered as an oral capsule(s) once daily<br>* Other names: Inactive;|
| Experimental: P005672-HCl approximately 1.5 mg/kg/day<br>Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks | Drug: 50 mg P005672-HCl<br>* P005672-HCl administered as an oral capsule(s) once daily<br>* Other names: WC3035, Sarecycline;|
| Experimental: P005672-HCl approximately 3.0 mg/kg/day<br>Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks | Drug: 100 mg P005672-HCl<br>* P005672-HCl administered as an oral capsule(s) once daily<br>* Other names: WC3035, Sarecycline;|
| Placebo Comparator: Placebo<br>Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks | Drug: Placebo<br>* Dose-matched Placebo capsule administered as an oral capsule(s) once daily<br>* Other names: Inactive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit |  | Baseline (Week 0) to Final Visit (Up to Week 12) | 
| The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit. | Final Visit (Up to Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit |  | Baseline (Week 0) up to Week 12 | 
| The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |  | Baseline (Week 0) up to Week 12 | 
| The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |  | Baseline (Week 0) up to Week 12 | 
| The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |  | Baseline (Week 0) up to Week 12 | 
| The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit. | Baseline to Final Visit (Up to Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne