Wrinkles
Conditions
Brief summary
The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.
Detailed description
Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction. This study is a pilot study designed to determine feasibility of these procedures.
Interventions
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Females and males 2. In good health 3. Is 20-65 years of age 4. Has static and 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. Pregnant or lactating 2. Younger than 20 or older than 65 years of age 3. 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 4. Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region. 5. Is planning to use tretinoin or retinoic acid in the next 6 months 6. Has an active infection in the forehead or glabellar region (excluding mild acne) 7. Is allergic to cow's milk protein 8. Is allergic to albumin 9. Taking aminoglycoside 10. Is currently using anticoagulation therapy 11. Has a history of bleeding disorders 12. Has a mental illness 13. Unable to understand the protocol or to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin | At baseline and at 6 months | Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is: 0: no facial wrinkles 1. mild facial wrinkles 2. moderate facial wrinkles 3. severe facial wrinkling |
| Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin | At baseline and at 6 months | Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is: 0: no wrinkles 1. minimal wrinkles 2. mild wrinkles 3. moderate wrinkles 4. severe wrinkles |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMurad Alam, MD
Northwestern University
Outcome results
None listed