Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris

Study Overview
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Brief Summary
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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,

Detailed Description
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This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:

Official Title
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A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of VB-1953 Topical Gel When Applied Once or Twice Daily for 12 Weeks in Subjects With Moderate to Severe Inflammatory Facial Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: VB-1953 - 2%
* Drug: VB-1953 - 0% (Vehicle)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or non-pregnant females 9 to 45 years of age (inclusive) at the time of consent/assent. Have a clinical diagnosis of moderate to severe (Grade 3 or 4) facial acne vulgaris, as determined by the Investigator's Global Assessment (IGA). Have 20 to 50 inflammatory lesions (papules, pustules) on the face. Have 20 to 60 non-inflammatory lesions on the face. Exclusion Criteria: Has more than two (2) facial nodulocystic lesions. Female subject is pregnant, lactating, or is planning to become pregnant during the study. Has active nodulocystic acne or acne conglobata, acne fulminans, or other forms of acne (e.g., acne mechanica). In the opinion of the Investigator, the subject has a skin pathology or other medical condition that is clinically significant (e.g., obesity) and will preclude participation in the study. Has presence of any skin condition on the face (e.g., rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acnetiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) in the opinion of the Investigator that could interfere with the diagnosis or assessment of acne vulgaris or evaluation of the investigational product (IP) or requires the use of interfering topical or systemic therapy. Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.

Ages Eligible for Study
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Minimum Age: 9 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
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VB-1953 topical gel - 2% QD<br>VB-1953 topical gel - 2% QD | Drug: VB-1953 - 2%<br>* Topical Gel<br>|
| Experimental: VB-1953 topical gel - 2% BID<br>VB-1953 topical gel - 2% BID | Drug: VB-1953 - 2%<br>* Topical Gel<br>|
| Placebo Comparator: VB-1953 topical gel- 0% (Vehicle) QD<br>VB-1953 topical gel- 0% (Vehicle) QD | Drug: VB-1953 - 0% (Vehicle)<br>* Topical Gel<br>|
| Placebo Comparator: VB-1953 Vehicle<br>VB-1953 topical gel- 0% (Vehicle) BID | Drug: VB-1953 - 0% (Vehicle)<br>* Topical Gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory lesion counts | Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment of Inflammatory Acne (IGA) score | Proportion of subjects achieving success at Week 12, with success defined as Investigator's Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from Baseline. | 12 weeks | 
| Percent change in inflammatory lesion counts | Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12 | 12 weeks |