Facial Flushing
Conditions
Brief summary
The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing. This study is a pilot study designed to determine feasibility of these procedures.
Interventions
DRUGbotulinum toxin A
A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.
OTHERSaline Control
A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients 18-65 years of age with persistent facial flushing 2. Willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff.
Exclusion criteria
1. Unable to understand the protocol or give informed consent 2. Younger than 18 or older than 65 years of age 3. Females who are pregnant or lactating 4. Known hypersensitivity to BTX-A 5. Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics) 6. Subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma 7. Botulinum toxin injections in the past 6 months 8. Ablative laser procedure in the past 6 months 9. Radiofrequency device treatment in the past 6 months 10. Ultrasound device treatment in the past 6 months 11. Medium to deep chemical peel in the past 6 months 12. Temporary soft tissue augmentation material in the area to be treated in the past year 13. Semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years 14. Permanent soft tissue augmentation material in the area to be treated 15. 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. 16. Is planning to use tretinoin or retinoic acid in the next 6 months 17. Has an active infection in the forehead or glabellar region (excluding mild acne) 18. Is allergic to cow's milk protein 19. Is allergic to albumin 20. Is currently using anticoagulation therapy 21. Has a history of bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectrophotometer measurement | Baseline and 8 weeks | Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit |
Countries
United States
Outcome results
None listed