Status:
ACTIVE_NOT_RECRUITING
Treatment of Facial Flushing With Botulinum Toxin A Injections
Lead Sponsor:
Northwestern University
Conditions:
Facial Flushing
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Patients 18-65 years of age with persistent facial flushing
- 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
- Unable to understand the protocol or give informed consent
- Younger than 18 or older than 65 years of age
- Females who are pregnant or lactating
- Known hypersensitivity to BTX-A
- Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics)
- Subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma
- Botulinum toxin injections in the past 6 months
- Ablative laser procedure in the past 6 months
- Radiofrequency device treatment in the past 6 months
- Ultrasound device treatment in the past 6 months
- Medium to deep chemical peel in the past 6 months
- Temporary soft tissue augmentation material in the area to be treated in the past year
- Semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
- Permanent soft tissue augmentation material in the area to be treated
- 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.
- Is planning to use tretinoin or retinoic acid in the next 6 months
- Has an active infection in the forehead or glabellar region (excluding mild acne)
- Is allergic to cow's milk protein
- Is allergic to albumin
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02216838
Start Date
August 1 2014
End Date
December 1 2025
Last Update
January 31 2025
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611