Flushing, Rosacea, Rosacea, Erythematotelangiectatic
Conditions
Brief summary
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
Interventions
DEVICETransaricular vagus nerve stimulation (taVNS)
This 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)
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Seizure disorder or epilepsy * Trigeminal Neuralgia within the past year * Severe coronary disease or recent myocardial infarction within the past 5 years * Severe autonomic dysfunction (e.g., frequent syncope, hospitalization) * History of recurrent syncope or unexplained fainting * Use of brimonidine or oxymetazoline within the past 4 weeks * Use of beta-blockers, anticholinergics, or vagal-modulating drugs within the past 4 weeks * Severe phymatous rosacea * Ear deformity, piercings, or other condition that prevents the use of the taVNS device * Known hypersensitivity to electrode materials * Patients who are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 4 of Clinician's Erythema Assessment (CEA) | Week 4 | 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. |
| Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI) | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8 | Week 4, Week 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. |
| Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8 | Week 4, Week 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 |
| Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8 | Week 4, Week 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. |
| DermSat-7 score at week 4 & week 8 | Week 4, Week 8 | The DermSat7 is a 7-item, self-administered questionnaire designed to assess patient satisfaction with dermatologic treatments. It covers three domains - effectiveness (3 items), convenience (3 items), and overall satisfaction (1 item) - with responses on a 5-point (or 5-point) satisfaction scale, then transformed into a 0-100 scale so that higher scores indicate greater satisfaction. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8 | Week 4, Week 8 | The GAD-7 evaluates anxiety severity with scores ranging from 0 to 21, using a similar structure to the PHQ-9. Scores are categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21). |
| Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8 | Week 4, Week 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). |
Countries
United States
Contacts
CONTACTLiset Chacin
Outcome results
None listed