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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether botulinum toxin A, commonly known as Botox®, can treat facial flushing, a condition where the face frequently turns red. The study involves injecting Botox® on one side of the face and a harmless saline solution on the other to observe any differences. It is best suited for individuals aged 18 to 65 who experience persistent facial redness and have not recently undergone cosmetic procedures or have certain medical conditions. Participants must also understand and provide consent for the trial. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for botulinum toxin A?

Research has shown that botulinum toxin A, commonly known as Botox, is generally safe to use. One study found that mild side effects, such as headaches, were uncommon. Another review reported that after injection, some people experienced slight redness (24.6%), bruising (5.1%), and minor muscle effects (4.3%). These side effects are usually mild and resolve on their own.

Botox is already used for many medical and cosmetic treatments, which supports its safety. Although reports exist of Botox effects spreading to other parts of the body, these instances are rare. Overall, Botox is considered a safe option for treating conditions like facial flushing. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Botulinum Toxin A for facial flushing because it offers a novel approach compared to standard treatments like oral medications or topical creams. Unlike these traditional methods, which generally focus on reducing blood vessel activity or inflammation, Botulinum Toxin A directly targets the nerve signals responsible for flushing. This means it could provide more precise and potentially faster relief from symptoms. Additionally, its ability to deliver targeted results on just one side of the face allows researchers to compare its effectiveness directly, offering valuable insights into its potential as a reliable treatment option.

What evidence suggests that botulinum toxin A might be an effective treatment for facial flushing?

Research has shown that botulinum toxin A, commonly known as Botox®, can help reduce facial redness. In this trial, participants will receive Botox on one side of the face and saline injections on the other side as a control. In a study with 24 patients, those who received Botox experienced less facial redness. Another study found that the redness score, which measures the severity of redness, decreased significantly after treatment. Additionally, research suggests Botox effectively treats rosacea, a condition causing facial redness, with few side effects. Overall, evidence supports Botox as a promising option for reducing facial redness and improving skin appearance. ^{6 7 8 9 10}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9515256/

Botulinum Toxin A Alleviates Persistent Erythema and ... In a prospective study [10], an open randomized controlled trial of 24 patients with facial flushing showed that the symptoms were improved ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38232350/

Efficacy of Botulinum Toxin in the Treatment of Cutaneous ... The most frequent outcome reported was a clinical flushing score, which significantly decreased by 1.25 points overall (95% confidence interval ...

3. cureus.com cureus.com/articles/211037-the-efficacy-and-safety-of-botulinum-toxin-a-for-the-treatment-of-rosacea-a-systematic-review.pdf

The Efficacy and Safety of Botulinum Toxin A ... BoNT-A seems to be effective in alleviating the symptoms of rosacea with a low rate of adverse events.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/5596030

Assessing the Efficacy and Safety of Intradermal Injection ... Our findings indicate that BTX microdrop therapy is effective for treating ETR, with better results at a 1 U injection volume per point. This ...

5. mdpi.com mdpi.com/2813-0413/4/3/31

Evaluating the Preventive Role of Botulinum Toxin in Facial ... These results suggest that intradermal BTX is effective and well tolerated in reducing facial erythema and improving skin quality in rosacea patients ...

6. media.allergan.com media.allergan.com/actavis/actavis/media/allergan-pdf-documents/safety-data-sheets/Botox%20Drug%20product.PDF

SAFETY DATA SHEET This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product.

7. cureus.com cureus.com/articles/211037-the-efficacy-and-safety-of-botulinum-toxin-a-for-the-treatment-of-rosacea-a-systematic-review

The Efficacy and Safety of Botulinum Toxin A for ... The pooled rates of post-injection localized erythema, ecchymosis, and facial muscle affection represented 24.6%, 5.1%, and 4.3%, respectively.

8. avalonfamilycare.com avalonfamilycare.com/wp-content/uploads/2021/03/BOTOX-Cosmetic-Nancy-BA.pdf

BOTOX® Cosmetic (onabotulinumtoxinA) Important ... Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6910814/

Botulin Toxin Use in Rosacea and Facial Flushing Treatment Reported adverse effect to BTX treatment is rare and limited to a mild headache. In conclusion, the innovative applications for BTX use in rosacea and facial ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7874868/

The whole truth about botulinum toxin – a review - PMC Treatment with botulinum toxin is widely viewed as safe, effective and largely devoid of serious side effects. Sequelae that can occur at any site after a ...