Treatment of Facial Flushing With Botulinum Toxin A Injections

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial

Conditions
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Facial Flushing

Intervention / Treatment
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* Drug: botulinum toxin A
* Other: Saline Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin A<br>This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections. | Drug: botulinum toxin A<br>* A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.<br>* Other names: Botox;|
| Placebo Comparator: Saline Control<br>This study is randomized, which means the subject will be randomly assigned (like a flip of a coin) to receive botox on the right or left side of the face and saline injections on the other side. Only one side of the face will receive botox injections. | Other: Saline Control<br>* A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectrophotometer measurement | Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit | Baseline and 8 weeks |