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

Northwestern University

Status: Completed

Conditions: Pain

Treatments: Procedure: 32-gauge needle; Procedure: 30-gauge needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01981174

STU84470

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. In good health
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

1. Younger than 25 or older than 70 years of age

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

30-gauge needle

Active Comparator group

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. 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.

Treatment:

Procedure: 30-gauge needle

32-gauge needle

Active Comparator group

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. 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.

Treatment:

Procedure: 32-gauge needle