rosacea
Conditions
Interventions
FMT group:FMT capsule
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Patients with clinical diagnosis of rosacea (according to the 2017 edition of the diagnostic criteria of the National Rosacea Expert Committee); 2. Age >=18 and <=50 years old, gender is not limited; 3. Persistent facial erythema; 4. Accompanied by nerve-related symptoms, such as burning and tingling; 5. Symptoms need to show sensitivity to specific triggers, such as emotional stress, temperature fluctuations, sun exposure, spicy diet and other aggravating factors; 6. Facial erythema is ineffective to conventional treatment, including antibiotics (metronidazole, doxycycline, minocycline), oral isotretinoin, and oral ß blockers; 7. Agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating patients, as well as those planning pregnancy. All female participants of childbearing potential must undergo a serum or urine HCG test prior to enrollment, and those with a positive result will be excluded; 2.Patients with moderate-to-severe phymatous or ocular manifestations of rosacea; 3.Patients with systemic diseases; 4.Patients with contraindications to FMT, including those with severe immunodeficiency (e.g., patients receiving immunosuppressive therapy after organ transplantation, patients with advanced HIV/AIDS, or congenital immunodeficiency), active or uncontrolled gastrointestinal diseases (e.g., acute intestinal obstruction, intestinal perforation, severe acute flare of inflammatory bowel disease, intra-abdominal abscess), severe allergic constitution or a known history of allergy to transplant material, and patients with known or potential high risk of infection (e.g., patients with active chronic hepatitis B or C virus infection); 5.Patients with a history of severe psychiatric disorders; 6.Patients who have received systemic treatment with conventional drugs within 4 weeks prior to the trial or oral isotretinoin within 6 months prior to the trial; 7.Patients with other facial diseases (e.g., seborrheic dermatitis, dermatomyositis, systemic lupus erythematosus); 8.Patients who have used antibiotics or probiotics within 1 month prior to the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician’s Erythema Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| patient’s self-assessment scale;Assessment of flushing severity;investigator’s global assessment;VAS(Visual Analog Scale);Quality of life assessment of rosacea;The score of migraine;Depression Anxiety and Stress Scale;Multispectral Facial Imaging;Skin Physiological Function Assessment; | — |
Countries
China
Contacts
Public ContactLi fulun
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed