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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: 30-gauge needle
* Procedure: 32-gauge needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30-gauge needle<br>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. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular. | Procedure: 30-gauge needle<br> <br> |
| Active Comparator: 32-gauge needle<br>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. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular. | Procedure: 32-gauge needle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score (VAS) pain rating after each side is injected | 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. | 1 hour on Treatment day |