A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections

Completed · Not applicable

Conditions studied: Pain

In brief

The purpose of this study is to compare the levels of pain resulting from injections of Botox® for wrinkles on the forehead and between the eyes using two different sized needles (32 gauge and 30 gauge needles).

Key facts

Study ID

NCT01981174

Run by

Northwestern University

People needed

20

Starts

2013-11-01

Expected to finish

2014-01-01

Last updated by the study team

2021-12-06

Who can join

Age: 25 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• In good health
• Is a female
• Is 25-70 years of age
• Has moderate dynamic forehead/glabellar wrinkles
• Has willingness and the ability to understand and provide informed consent and communicate with the study staff

You may not qualify if…

• Younger than 25 or older than 70 years of age
• Pregnant or lactating
• Is a male
• Has received the following treatments in the forehead or glabellar region:
• botulinum toxin injections in the past 6 months
• ablative laser procedure in the past 6 months
• radiofrequency device treatment in the past 6 months
• ultrasound device treatment in the past 6 months
• medium to deep chemical peel in the past 6 months
• temporary soft tissue augmentation material in the area to be treated in the past year
• semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
• permanent soft tissue augmentation material in the area to be treated
• Has an active infection in the forehead or glabellar region (excluding mild acne)
• Is allergic to cow's-milk protein
• Is allergic to albumin
• Taking aminoglycoside
• Is currently using anticoagulation therapy
• Has a history of bleeding disorders
• Has a mental illness
• Unable to understand the protocol or to give informed consent

Where it is running

• Northwestern University Department of Dermatology — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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