Treatment of Facial Flushing With Botulinum Toxin A Injections
Primary Purpose
Facial Flushing
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
botulinum toxin A
Saline Control
Sponsored by
About this trial
This is an interventional treatment trial for Facial Flushing
Eligibility Criteria
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
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
botulinum toxin A
Saline Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Spectrophotometer measurement
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
Secondary Outcome Measures
Full Information
NCT ID
NCT02216838
First Posted
August 12, 2014
Last Updated
February 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT02216838
Brief Title
Treatment of Facial Flushing With Botulinum Toxin A Injections
Official Title
Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Flushing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin A
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
botulinum toxin A
Other Intervention Name(s)
Botox
Intervention Description
A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.
Intervention Type
Other
Intervention Name(s)
Saline Control
Intervention Description
A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side
Primary Outcome Measure Information:
Title
Spectrophotometer measurement
Description
Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Facial Flushing With Botulinum Toxin A Injections
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