NCT00628472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

February 25, 2008

Last Update Submit

April 29, 2024

Conditions

Pain

Keywords

botulinum toxin abotoxDecreasing botox injection paininjections

Outcome Measures

Primary Outcomes (1)

  • Decrease pain on injection for treatment intervention assessed on a 10 point scale

    At time of intervention

Interventions

botulinum type aDRUG

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

Also known as: Botox

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • David M Ozog, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair-Dermatology

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

US(1)