Treatment of Facial Flushing with Botulinum Toxin a Injections

Northwestern University

Status and phase: Active, not recruiting; Phase 4

Conditions: Facial Flushing

Treatments: Other: Saline Control; Drug: botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT02216838

STU97514

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

botulinum toxin A

Experimental group

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.

Treatment:

Drug: botulinum toxin A

Saline Control

Placebo Comparator group

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.

Treatment:

Other: Saline Control