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Treatment of Facial Flushing With Botulinum Toxin A Injections

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ClinicalTrials.gov Identifier: NCT02216838
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Facial Flushing Drug: botulinum toxin A Other: Saline Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Facial Flushing With Botulinum Toxin A Injections: A Split-Face, Double-blinded, Randomized Control Trial
Study Start Date : August 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: 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




Primary Outcome Measures :
  1. Spectrophotometer measurement [ Time Frame: Baseline and 8 weeks ]
    Spectrophotometer measurement as the percent resolution on each follow up visit compared to baseline visit



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216838


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University

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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02216838     History of Changes
Other Study ID Numbers: STU97514
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Facies
Flushing
Disease Attributes
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents