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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30-gauge needle | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30-gauge needle | Procedure |
| ||
| 32-gauge needle |
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26352252 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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