Safety and Efficacy of the Use of Botox on Acne

Phase 2

Terminated

Conditions: Acne Vulgaris

Interventions: Drug: Botulinum Neurotoxin Type A
Drug: Bacteriostatic saline

Registration Number: NCT00765375

Lead Sponsor: DeNova Research

Brief Summary: • 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: • 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botox and Placebo on each side of face	Botulinum Neurotoxin Type A	Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)
Botox and Placebo on each side of face	Bacteriostatic saline	Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)

Primary Outcome Measures

Name	Time	Method
Change in Mean Lesion Count From Baseline at 90 Days	Baseline and 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)

Secondary Outcome Measures