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Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

This study has been completed.
Sponsor:
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00628472
First received: February 25, 2008
Last updated: March 4, 2008
Last verified: May 2007
History of Changes
  Purpose

This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.


Condition Intervention
Pain
 Drug: botulinum type a

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Decrease pain on injection for treatment intervention assessed on a 10 point scale [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: January 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: botulinum type a
    12 Units total were injected into 6 sites in the glabellar complex to determine if injecting through the follicle versus a traditional approach would decrease patient discomfort
    Other Name: Botox
Detailed Description:

Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach.

Design: Prospective, randomized, single-blinded study.

Setting: Academic dermatology department.

Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection.

Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally.

Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • No prior history of botulinum toxin
  • Age 25-55

Exclusion Criteria:

  • Male
  • Prior history of botulinum toxin
  • Neuromuscular disorders
  • Aminoglycoside therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628472

Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: David M Ozog, MD Henry Ford Health System
  More Information

No publications provided

Responsible Party: David M Ozog, MD, FAAD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00628472     History of Changes
Other Study ID Numbers: IRB 4300
Study First Received: February 25, 2008
Last Updated: March 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
botulinum toxin a
botox
Decreasing botox injection pain
injections

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013