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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: 30-gauge needle; Procedure: 32-gauge needle

• Registration Number: NCT01981174
• Lead Sponsor: Northwestern University

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).

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
30-gauge needle	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.
32-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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States