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Safety and Efficacy of the Use of Botox on Acne

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ClinicalTrials.gov Identifier: NCT00765375
Recruitment Status : Terminated (Investigator decision)
First Posted : October 2, 2008
Results First Posted : April 30, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research

September 30, 2008
October 2, 2008
August 29, 2012
April 30, 2015
June 29, 2018
September 2008
December 2008   (Final data collection date for primary outcome measure)
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)
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) [ Time Frame: 90 days ]
Complete list of historical versions of study NCT00765375 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of the Use of Botox on Acne
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
• 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)
• 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: Botulinum Neurotoxin Type A
    1.5-3 units of Botox/lesion
    Other Name: Botox
  • Drug: Bacteriostatic saline
    .1 cc bacteriostatic saline/lesion
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)
Interventions:
  • Drug: Botulinum Neurotoxin Type A
  • Drug: Bacteriostatic saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
20
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00765375
BTX-D-001
Yes
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Steven H. Dayan, DeNova Research
DeNova Research
Not Provided
Principal Investigator: Steven H Dayan, MD F.A.C.S. DeNova Research
DeNova Research
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP