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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

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Botulinum Neurotoxin Type A Drug: Bacteriostatic saline Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Botox

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765375


Locations
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United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
DeNova Research
Investigators
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Principal Investigator: Steven H Dayan, MD F.A.C.S. DeNova Research
More Information
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Responsible Party: Steven H. Dayan, Medical Director, DeNova Research
ClinicalTrials.gov Identifier: NCT00765375    
Other Study ID Numbers: BTX-D-001
First Posted: October 2, 2008    Key Record Dates
Results First Posted: April 30, 2015
Last Update Posted: June 29, 2018
Last Verified: May 2018
Keywords provided by Steven H. Dayan, DeNova Research:
acne
Botox
cosmetic treatments
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents