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Safety and Efficacy of the Use of Botox on Acne

This study has been terminated.
(Investigator decision)
Sponsor:
Information provided by:
DeNova Research
ClinicalTrials.gov Identifier:
NCT00765375
First received: September 30, 2008
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

• 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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:

MedlinePlus related topics: Acne Botox
U.S. FDA Resources

Further study details as provided by DeNova Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Botulinum Neurotoxin Type A (Botox)
 Drug: Botulinum Neurotoxin Type A
1.5-3 units of Botox/lesion
Other Name: Botox
Placebo Comparator: 2
Saline Solution
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765375

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

No publications provided

Responsible Party: Steven H. Dayan, MD FACS, DeNova Research
ClinicalTrials.gov Identifier: NCT00765375     History of Changes
Other Study ID Numbers: BTX-D-001
Study First Received: September 30, 2008
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by DeNova Research:
acne
Botox
cosmetic treatments

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
 Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013