Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort - Full Text View

Sponsored by:	Henry Ford Health System
Information provided by:	Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00628472

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

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin Botulinum toxin A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Single Group Assignment
Official Title:	Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

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:

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

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

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

Keywords provided by Henry Ford Health System:

botulinum toxin a
botox
Decreasing botox injection pain
injections

Study placed in the following topic categories:

Botulinum Toxins
Pain
Botulinum Toxin Type A

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009