A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections
NCT ID: NCT01981174
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2013-11-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
TRIPLE
Study Groups
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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.
30-gauge needle
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.
32-gauge needle
Interventions
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30-gauge needle
32-gauge needle
Eligibility Criteria
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Inclusion Criteria
2. Is a female
3. Is 25-70 years of age
4. Has moderate dynamic forehead/glabellar wrinkles
5. Has willingness and the ability to understand and provide informed consent and communicate with the study staff
Exclusion Criteria
2. Pregnant or lactating
3. Is a male
4. Has received the following treatments in the forehead or glabellar region:
1. botulinum toxin injections in the past 6 months
2. ablative laser procedure in the past 6 months
3. radiofrequency device treatment in the past 6 months
4. ultrasound device treatment in the past 6 months
5. medium to deep chemical peel in the past 6 months
6. temporary soft tissue augmentation material in the area to be treated in the past year
7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
8. permanent soft tissue augmentation material in the area to be treated
5. Has an active infection in the forehead or glabellar region (excluding mild acne)
6. Is allergic to cow's-milk protein
7. Is allergic to albumin
8. Taking aminoglycoside
9. Is currently using anticoagulation therapy
10. Has a history of bleeding disorders
11. Has a mental illness
12. Unable to understand the protocol or to give informed consent
25 Years
70 Years
FEMALE
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Department of Dermatology
Chicago, Illinois, United States
Countries
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References
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Alam M, Geisler A, Sadhwani D, Goyal A, Poon E, Nodzenski M, Schaeffer MR, Tung R, Minkis K. Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin Type A Injections: A Randomized Clinical Trial. JAMA Dermatol. 2015 Nov;151(11):1194-9. doi: 10.1001/jamadermatol.2015.2232.
Other Identifiers
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STU84470
Identifier Type: -
Identifier Source: org_study_id