Erythematotelangiectatic rosacea (ETR)
Conditions
Interventions
sham stimulation group:iTBS sham stimulation
iTBS Treatment Group:iTBS Treatment
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years (inclusive), with no restriction on gender. 2. Meeting the diagnostic criteria for erythematotelangiectatic rosacea (ETR) specified in the Chinese Guidelines for the Diagnosis and Treatment of Rosacea (2021 Edition): persistent erythema in the central facial area (nose, cheeks, forehead and chin), with or without telangiectasia and burning sensation, and absence of obvious papules and pustules. 3. Meeting the definition of refractory rosacea: having received at least one standard treatment (e.g., minocycline, topical brimonidine gel, intense pulsed light/dye laser therapy, oral hydroxychloroquine, etc.) for no less than 4 consecutive weeks within the past 3 months, with poor clinical response (a decrease of = 2 points (0–4 scoring scale). 5. No rosacea-related treatments administered within the past month, and a commitment to refrain from additional interventions throughout the trial period. 6. Voluntary participation in this study with signed informed consent documents (including consent for MRI/fMRI examination and facial skin lesion biopsy). Participants shall comply with study and follow-up procedures, and cooperate in the observation of adverse events and therapeutic effects.
Exclusion criteria
Exclusion criteria: 1.Patients with papulopustular, ocular or phymatous rosacea; 2.Participation in any clinical trial of investigational drugs within one month prior to enrollment; 3.Current use of medications that may affect rosacea symptoms, including psychoneurological drugs such as gabapentin and duloxetine, as well as minocycline hydrochloride and isotretinoin and other drugs interfering with rosacea conditions; 4.Bradycardia, severe diseases of vital organs (heart, liver, lung, kidney etc.), hematological disorders, or any other conditions deemed ineligible for this clinical trial by the investigators. 5.Diagnosis of malignant tumor, general debilitation or immunodeficiency. 6.Comorbid facial acne, atopic dermatitis, corticosteroid-dependent dermatitis or other facial skin disorders; 7.History of epilepsy, family history of epilepsy, tic disorders, or other psychiatric and neurological diseases that may result in poor cooperation. 8.Presence of intracranial metallic foreign bodies, cardiac pacemakers, cardiac stents, cochlear implants, metal dentures, claustrophobia, or other contraindications for MRI examination. 9.Markedly elevated intracranial pressure or intracranial hemangioma. 10.Pregnant or lactating females, or those planning to conceive during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Erythema Assessment (CEA) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| RosaQoL (Rosacea Quality of Life Questionnaire);Pittsburgh Sleep Quality Index (PSQI);Global Flushing Severity Scale (GFSS);GAD-7 Anxiety Severity Assessment;Visual Analogue Scale (VAS) for Migraine;Patient Self-Assessment Questionnaire (PSA);Fatigue Severity Scale (FSS);PHQ-9 Depression Severity Assessment;magnetic resonance imaging (MRI) indices; | — |
Countries
China
Contacts
Public ContactJian Li
The First Affiliated Hospital of Army Medical University
Outcome results
None listed