Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628472
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 5, 2008
Information provided by:
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.

Condition or disease Intervention/treatment
Pain Drug: botulinum type a

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort
Study Start Date : January 2007
Primary Completion Date : May 2007
Study Completion Date : May 2007

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

Primary Outcome Measures :
  1. Decrease pain on injection for treatment intervention assessed on a 10 point scale [ Time Frame: At time of intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Male
  • Prior history of botulinum toxin
  • Neuromuscular disorders
  • Aminoglycoside therapy

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 identifier (NCT number): NCT00628472

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

Responsible Party: David M Ozog, MD, FAAD, Henry Ford Health System Identifier: NCT00628472     History of Changes
Other Study ID Numbers: IRB 4300
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: May 2007

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

Additional relevant MeSH terms:
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs