A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
Status: | Active, not recruiting |
---|---|
Conditions: | Cosmetic |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 20 - 65 |
Updated: | 2/17/2019 |
Start Date: | November 2013 |
End Date: | December 2019 |
Treatment of Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial
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.
versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical
lines between the eyebrows) wrinkles.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials