Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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 taVNS. The particicpants will be followed for an additional 4-weeks following the intervention period to evaluate the durability of the results
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years of age and older
Dermatologist confirmed diagnosis of rosacea
Clinician's Erythema Assessment of at least 3 (moderate to severe disease)
Willingness to adhere to current rosacea regimen without additions or laser treatments (e.g. PDL) during the study period.
Disqualifiers
Changes to rosacea regimen (prescription topical or oral medications) within 4 weeks of randomization.
Facial hair, tattoos, or other characteristics that would interfere with erythema assessments
History of symptomatic cardiac arrythmias (e.g. heart block, sick sinus syndrome, bradyarrhythmia)
Presence of a pacemaker, implanted defibrillator, or neurostimulator
Trial design
Design model
Single group
Treatments tested in this trial
Transaricular vagus nerve stimulation (taVNS)
DeviceThis project consists of a 4-week trial of transaricular vagus nerve stimulation (taVNS) for rosacea. Participation is expected to last for a total duration of 8 weeks (4 week active intervention period)
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: RosaceaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)
The CEA is a static 5-point grading scale of facial erythema severity. The scale is 0 to 4. A positive result, means that the erythema, redness was reduced. A negative result indicates that the erythema increased.
Time frame
Week 42
Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI)
The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Time frame
Week 4Secondary outcomes
1
Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8
The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Time frame
Week 4, Week 82
Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8
The GFSS is a 0-10 numeric rating scale assessing facial flushing symptoms including redness, warmth, tingling, or itching over the past 24 hours, with scores ranging from: 0 (did not have), 1-3 (mild), 4-6 (moderate), 7-9 (severe), 10 (extreme).
Time frame
Week 4, Week 83
Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8
The CEA is a static 5-point grading scale of facial erythema severity. The scale is 0 to 4. A positive result, means that the erythema, redness, was reduced. A negative result indicates that the erythema increased.
Time frame
Week 4, Week 84
Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8
The PHQ-9 is a widely used tool for assessing depression severity, with scores ranging from 0 to 27 based on the frequency of symptoms over the past two weeks
Time frame
Week 4, Week 8Sponsors and contacts
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Source ClinicalTrials.gov