10 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for Rosacea

LC
Overseen ByLiset Chacin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage rosacea, a skin condition that causes redness and flushing. It uses a device called transauricular vagus nerve stimulation (taVNS) to determine if it reduces these symptoms over four weeks. Individuals with rosacea who experience moderate to severe redness and can maintain their current treatment routine may be suitable candidates. The trial seeks to determine if the benefits persist for an additional four weeks after stopping the treatment. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments for rosacea.

Do I have to stop taking my current medications for the trial?

You can continue your current rosacea medications, but you cannot make any changes to them during the study. If you've used certain medications like brimonidine, oxymetazoline, beta-blockers, anticholinergics, or vagal-modulating drugs in the past 4 weeks, you may not be eligible to participate.

What prior data suggests that this device is safe for treating rosacea?

Studies have shown that transauricular vagus nerve stimulation (taVNS) is generally well-tolerated. Research indicates that side effects are rare. In one review, only 5.6% of participants using taVNS experienced side effects, most of which were minor.

Additionally, a study found 30 serious side effects across several trials, but none were directly linked to taVNS. This suggests the treatment is safe. Overall, evidence suggests that taVNS is safe for humans, with few and mostly mild side effects.12345

Why are researchers excited about this trial?

Unlike the standard treatments for rosacea, which typically include topical creams, oral antibiotics, and laser therapy, transauricular vagus nerve stimulation (taVNS) offers a novel approach by targeting the nervous system. Researchers are excited about taVNS because it uses a non-invasive method to stimulate the vagus nerve through the ear, potentially reducing inflammation associated with rosacea. This mechanism is different from conventional treatments and could offer a new, drug-free option for managing symptoms.

What evidence suggests that transaricular vagus nerve stimulation is effective for rosacea?

Research has shown that transaricular vagus nerve stimulation (taVNS), which participants in this trial will receive, can help reduce rosacea symptoms such as facial redness and flushing. In studies, individuals who received taVNS experienced noticeable improvements in these symptoms compared to those who did not receive the treatment. Participants also reported reduced anxiety, which often accompanies rosacea. This treatment has also proven beneficial for other conditions like migraines and depression, suggesting it may help calm the nervous system. Overall, these findings indicate that taVNS could be a promising option for managing rosacea symptoms.12345

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with rosacea who have at least moderate redness or flushing. Participants must be willing to stick to their current rosacea treatment plan and not start any new treatments, including laser therapy, during the study.

Inclusion Criteria

I am 18 years old or older.
I have been diagnosed with rosacea by a dermatologist.
My skin redness is moderate to severe, as assessed by my doctor.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week trial of transcutaneous auricular vagus nerve stimulation (taVNS) for rosacea

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment to evaluate the durability of the results

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transaricular vagus nerve stimulation (taVNS)

Trial Overview

The study tests a device called transcutaneous auricular vagus nerve stimulation (taVNS) over 4 weeks in people with rosacea. All participants receive the same treatment and are monitored for another 4 weeks after finishing.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: RosaceaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41060641/

Transcutaneous Auricular Vagus Nerve Stimulation ...

Transcutaneous auricular vagus nerve stimulation (taVNS) therapy may be beneficial for treating ETR; however, it has not been rigorously ...

Transcutaneous Auricular Vagus Nerve Stimulation ...

This project consists of an 4-week trial of transaricular vagus nerve stimulation (taVNS) for rosacea. Participation is expected to last for ...

Transcutaneous Auricular Vagus Nerve Stimulation Treatment ...

A single arm, pilot study among individuals with rosacea and at least moderate flushing or rednesss will be enrolled in a 4-week trial of ...

Transcutaneous Auricular Vagus Nerve Stimulation...

The primary outcome was CEA score after 3 weeks of treatment. The secondary outcomes included improvements in erythema and facial flushing, sleep disorders, ...

Nerve Stimulation Improves Rosacea Outcomes in Trial

Transcutaneous auricular vagus nerve stimulation reduced facial flushing and erythema in patients with rosacea versus sham stimulation in a ...