Safety and Efficacy of the Use of Botox on Acne

Overview

• 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)

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • Drug: Botulinum Neurotoxin Type A
    • 1.5-3 units of Botox/lesion
  • Drug: Bacteriostatic saline
    • .1 cc bacteriostatic saline/lesion

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in Mean Lesion Count From Baseline at 90 Days
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • DeNova Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven H. Dayan, Medical Director – DeNova Research
  • Overall Official(s)
    • Steven H Dayan, MD F.A.C.S., Principal Investigator, DeNova Research

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