Safety and Efficacy of the Use of Botox on Acne

Study Overview
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Brief Summary
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• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)

Detailed Description
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• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.

Official Title
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Double-Blind, Randomized, Placebo-Controlled Study to Determine the Safety and the Efficacy of Using Botulinum Neurotoxin Type A Injections for Subjects With Mild to Moderate Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Botulinum Neurotoxin Type A
* Drug: Bacteriostatic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the age of 18 and 50 years of age Not pregnant and negative pregnancy test, not planning on getting pregnant Mild to moderate bilateral acne lesions on the face Able to understand the requirements of the study and sign an Informed Consent Form Have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study) Skin types I, II, III, IV and V Exclusion Criteria: Subject has skin type VI Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease Concurrent skin conditions affecting area to be treated Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment Prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation Open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi in areas to be treated? Permanent or semi-permanent dermal filler treatment within the last 6 months Medium or deep depth chemical peel resurfacing procedure within 3 months of treatment or during this clinical evaluation Has used oral isotretinoin (Accutane) within 6 months, or use of topical isotretinoin within 3 months, of initial treatment or during this clinical evaluation Prior light /laser treatments at target locations within 3 months of enrollment or during the course of this clinical evaluation Any physical or mental condition which, in the investigator's opinion would make it unsafe for the subject to participate in the clinical evaluation Use of oral antibiotics for acne and/or medication that cause photosensitivity within 2 weeks of initial treatment Participation in a study of another investigational devices or drugs within 3 months of enrollment Subject shows symptoms of a hormonal disorder Subject cannot be treated for (past or present) any form of treatment of active cancer or having a history of skin cancer or any other cancer in the area to be treated Subject is currently using immunosuppressive medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox and Placebo on each side of face<br>Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion) | Drug: Botulinum Neurotoxin Type A<br>* 1.5-3 units of Botox/lesion<br>* Other names: Botox;Drug: Bacteriostatic saline<br>* .1 cc bacteriostatic saline/lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Lesion Count From Baseline at 90 Days | To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA) | Baseline and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botox, acne, cosmetic treatments