Treatment of Facial Flushing With Botulinum Toxin A Injections

Facial Flushing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02216838
• Other study ID #: STU97514
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Flushing
• Facies
• Flushing

Intervention

Drug:
• botulinum toxin A
A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spectrophotometer measurement	Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit	Baseline and 8 weeks