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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 25, 2008

Last Updated Date

March 4, 2008

Start Date ^†

January 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00628472 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

Official Title ^†

Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Randomized, Single Blind (Subject), Single Group Assignment

Condition ^†

Pain

Intervention ^†

Drug: botulinum type a

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00628472

Responsible Party

David M Ozog, MD, FAAD, Henry Ford Health System

Secondary IDs ^††

Study Sponsor ^†

Henry Ford Health System

Collaborators ^††

Investigators ^†

Principal Investigator:

David M Ozog, MD

Henry Ford Health System

Information Provided By

Henry Ford Health System

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.