Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02216838

Treatment of Facial Flushing With Botulinum Toxin A Injections

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Drug

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

Other names: Botox

Saline Control

Other

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 outcomes

  1. Spectrophotometer measurement

    Time frame: Baseline and 8 weeks

    Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2014
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.