A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 30-gauge needle 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
|
| Active Comparator: 32-gauge needle 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
|
Outcome Measures
Primary Outcome Measures
- Visual analog score (VAS) pain rating after each side is injected [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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In good health
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Is a female
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Is 25-70 years of age
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Has moderate dynamic forehead/glabellar wrinkles
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Has willingness and the ability to understand and provide informed consent and communicate with the study staff
Exclusion Criteria:
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Younger than 25 or older than 70 years of age
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Pregnant or lactating
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Is a male
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Has received the following treatments in the forehead or glabellar region:
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botulinum toxin injections in the past 6 months
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ablative laser procedure in the past 6 months
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radiofrequency device treatment in the past 6 months
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ultrasound device treatment in the past 6 months
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medium to deep chemical peel in the past 6 months
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temporary soft tissue augmentation material in the area to be treated in the past year
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semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
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permanent soft tissue augmentation material in the area to be treated
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Has an active infection in the forehead or glabellar region (excluding mild acne)
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Is allergic to cow's-milk protein
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Is allergic to albumin
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Taking aminoglycoside
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Is currently using anticoagulation therapy
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Has a history of bleeding disorders
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Has a mental illness
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Unable to understand the protocol or to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University Department of Dermatology | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: Murad Alam, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU84470