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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
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Flushing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
August 12, 2014
Last Updated
February 17, 2023
Sponsor
Northwestern University
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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

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Treatment of Facial Flushing With Botulinum Toxin A Injections

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