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Safety and Efficacy of the Use of Botox on Acne

This study has been terminated.
(Investigator decision)
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research Identifier:
First received: September 30, 2008
Last updated: April 28, 2015
Last verified: April 2015
• 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)

Condition Intervention Phase
Acne Vulgaris
Drug: Botulinum Neurotoxin Type A
Drug: Bacteriostatic saline
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • Change in Mean Lesion Count From Baseline at 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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)

Enrollment: 5
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Botulinum Neurotoxin Type A
1.5-3 units of Botox/lesion
Other Name: Botox
Drug: Bacteriostatic saline
.1 cc bacteriostatic saline/lesion

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00765375

United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
DeNova Research
Principal Investigator: Steven H Dayan, MD F.A.C.S. DeNova Research
  More Information

Responsible Party: Steven H. Dayan, Medical Director, DeNova Research Identifier: NCT00765375     History of Changes
Other Study ID Numbers: BTX-D-001 
Study First Received: September 30, 2008
Results First Received: August 29, 2012
Last Updated: April 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by DeNova Research:
cosmetic treatments

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on October 21, 2016