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Completed

NCT Number: NCT01981174

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

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. This study is a pilot study designed to determine feasibility of these procedures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

30-gauge needle

Procedure

32-gauge needle

Procedure

Primary outcomes

  1. Visual analog score (VAS) pain rating after each side is injected

    Time frame: 1 hour on Treatment day

    Subjects will rate pain using the visual analog score (VAS 1-10) after each side is injected using the 30 or 32 gauge needles. Lower values represents less pain; higher values represents more pain.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2013
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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