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Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

Not Applicable
Completed
Conditions
Pain
Registration Number
NCT00628472
Lead Sponsor
Henry Ford Health System
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
21
Inclusion Criteria
  • Female
  • No prior history of botulinum toxin
  • Age 25-55
Exclusion Criteria
  • Male
  • Prior history of botulinum toxin
  • Neuromuscular disorders
  • Aminoglycoside therapy

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Decrease pain on injection for treatment intervention assessed on a 10 point scaleAt time of intervention
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

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