Treatment of Facial Flushing With Botulinum Toxin A Injections

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Facial Flushing
• Intervention / Treatment: Drug: botulinum toxin A; Other: Saline Control

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: botulinum toxin A; 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; A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.; Other Names: Botox
Placebo Comparator: Saline Control; 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; A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimated): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Skin Manifestations; Flushing; Facies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: STU97514