Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
12 augusti 2026 uppdaterad av: John Barbieri, Brigham and Women's Hospital
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot 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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
10
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Liset Chacin
- Telefonnummer: 617-264-5926
- E-post: lchacin@bwh.harvard.edu
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02461
- Rekrytering
- Brigham and Women's Hospital
-
Kontakt:
- John Barbieri, MD, MBA
- Telefonnummer: 617-264-5926
- E-post: jbarbieri@bwh.harvard.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Rosacea
|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)
Tidsram: 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.
|
Week 4
|
|
Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI)
Tidsram: 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.
|
Week 4
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8
Tidsram: 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.
|
Week 4, Week 8
|
|
Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8
Tidsram: 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).
|
Week 4, Week 8
|
|
Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8
Tidsram: 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
|
Week 4, Week 8
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8
Tidsram: 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).
|
Week 4, Week 8
|
|
Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8
Tidsram: 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.
|
Week 4, Week 8
|
|
DermSat-7 score at week 4 & week 8
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 maj 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
28 februari 2028
Studieregistreringsdatum
Först inskickad
15 maj 2026
Först inskickad som uppfyllde QC-kriterierna
15 maj 2026
Första postat (Faktisk)
20 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 augusti 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026P000835
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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