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Neurotoxin
Botulinum Toxin A for Facial Flushing
N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks
Summary
This trial will test the use of botulinum toxin A to see if it can help reduce facial flushing.
Who is the study for?
This trial is for adults aged 18-65 who experience persistent facial flushing and can give informed consent. It's not suitable for those with certain medical conditions like heart failure, bleeding disorders, or allergies to botox ingredients. Pregnant women, people on specific medications, or those who've had recent cosmetic treatments in the face are excluded.
What is being tested?
The study is testing whether botulinum toxin A (Botox®) injections can help treat facial flushing compared to a saline control. This pilot study aims to assess the feasibility of using Botox for this purpose.
What are the potential side effects?
Potential side effects may include localized pain at injection sites, muscle weakness near treated areas, headache, allergic reactions such as itching or rash, and flu-like symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Spectrophotometer measurement
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: botulinum toxin AExperimental Treatment1 Intervention
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.
Group II: Saline ControlPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
botulinum toxin A
2010
Completed Phase 4
~410
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,645 Previous Clinical Trials
958,578 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,564 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma in the past.You have received a radiofrequency device treatment in the past 6 months.You have had problems with bleeding in the past.You are taking medications that affect your muscles and nerves, like certain antibiotics.You have a known allergy or sensitivity to BTX-A.You have had a laser procedure done in the past 6 months.You have had temporary fillers injected in the area to be treated within the past year.You have permanent fillers or implants in the area that needs to be treated.You are allergic to the protein found in cow's milk.You are allergic to albumin, a protein commonly found in the blood.You are currently taking medication to prevent blood clotting.You are between 18 and 65 years old and experience ongoing redness in your face.You have received treatment with an ultrasound device in the last 6 months.You have had a strong chemical peel within the last 6 months.You plan to use tretinoin or retinoic acid in the next 6 months.You have an active infection on your forehead or between your eyebrows, except for mild acne.You have received botulinum toxin injections in the past 6 months.You have had a soft tissue augmentation procedure in the area to be treated within the past 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: botulinum toxin A
- Group 2: Saline Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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