Treatment of Facial Flushing With Botulinum Toxin A Injections

NCT02216838 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STU97514
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Flushing

Outcome Measures

Primary Outcomes (1)

• Spectrophotometer measurement

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

  Baseline and 8 weeks

Study Arms (2)

botulinum toxin A

EXPERIMENTAL

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

Saline Control

PLACEBO COMPARATOR

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

Interventions

botulinum toxin A DRUG

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

Also known as: Botox

botulinum toxin A

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

Saline Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Blushing

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)