Pain
Conditions
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.
Interventions
PROCEDURE30-gauge needle
PROCEDURE32-gauge needle
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed