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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosacea | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transaricular vagus nerve stimulation (taVNS) | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liset Chacin | Contact | 617-264-5926 | lchacin@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02461 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D005483 | Flushing |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Week 4, Week 8 |
| 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). | Week 4, Week 8 |
| 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. | Week 4, Week 8 |
| 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 | Week 4, Week 8 |
| Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 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). | Week 4, Week 8 |
| DermSat-7 score at 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. | Week 4, Week 8 |
| D013568 | Pathological Conditions, Signs and Symptoms |