Botulinum Toxin A for Facial Flushing

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Aminoglycoside antibiotics, Anticoagulants

Disqualifiers: Pregnancy, Hypersensitivity to BTX-A, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial requires that you do not use medications that interfere with neuromuscular functions, like certain antibiotics. If you're on such medications, you may need to stop them to participate.

What data supports the effectiveness of the drug Botulinum Toxin A for treating facial flushing?

Research shows that Botulinum Toxin A can effectively reduce facial flushing, as seen in a study where patients experienced significant improvement in their quality of life after treatment. Additionally, similar success has been observed in treating neck and chest wall flushing, suggesting its potential effectiveness for facial flushing as well. ^{1 2 3 4 5}

Is Botulinum Toxin A safe for treating facial flushing?

Botulinum Toxin A has been used safely for various skin conditions, including facial flushing, with few side effects reported. It has an excellent safety profile when used for dermatological purposes, although more studies are needed to fully understand its safety in all conditions. ^{4 6 7 8 9}

How does the drug Botulinum Toxin A differ from other treatments for facial flushing?

Botulinum Toxin A is unique because it works by blocking the release of certain chemicals in the nerves that cause blood vessels to widen, which helps reduce redness and warmth in the skin. Unlike other treatments, it is injected directly into the skin and has shown promising results in improving the quality of life for patients with facial flushing. ^{1 2 4 5 10}

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

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 are between 18 and 65 years old and experience ongoing redness in your face.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive botulinum toxin A injections on one side of the face and saline on the other side

8 weeks

Baseline and follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Botulinum Toxin A

Trial Overview 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.

Participant Groups

Group I: botulinum toxin A Experimental Treatment 1 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 Control Placebo Group 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Facial blanching due to neurotoxins: proposed mechanisms. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Successful use of Botulinum toxin-A for the treatment of neck and anterior chest wall flushing. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The use of botulinum toxin-A in the management of neck and anterior chest wall flushing: pilot study. [2013]

4. Iran pubmed.ncbi.nlm.nih.gov

Botulinum Toxin A in Treatment of Facial Flushing. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A split-face study using botulinum toxin type B to decrease facial erythema index. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Unlabeled uses of botulinum toxins: a review, part 2. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Unlabeled uses of botulinum toxins: a review, part 1. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Novel cutaneous uses for botulinum toxin type A. [2010]

10. North Macedonia pubmed.ncbi.nlm.nih.gov

Botulin Toxin Use in Rosacea and Facial Flushing Treatment. [2020]