vulvar lichen sclerosus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old; (2) No comorbidities of severe cardiac, pulmonary, renal, or hepatic dysfunction and metabolic diseases; (3) Subjects are willing to have no pregnancy plans and agree to use effective contraception (no sexual activity or barrier contraception by using a condom throughout the entire course of treatment with the study medication from screening to treatment with the study medication, and for 3 months after discontinuation of study medication); (4)Vulvar lichen sclerosus are definitively diagnosed by vulva biopsy; (5) Voluntarily participate in this clinical trial and can understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) patients with pregnancy; (2) patients with organic lesions of important organs; (3) patients with combined vulvar or cervical malignant lesions; (4) patients with acute or chronic inflammatory or infectious diseases (e.g., rheumatoid arthritis, lupus erythematosus, Crohn's disease), other cancers, and hematological disorders; (5) patients with known immune-suppressing disorders (including human immunodeficiency virus infection), low neutrophil or lymphocyte counts, or patients taking immunosuppressive drugs; (6) patients who have taken antibiotics or traditional Chinese medicine within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pruritus degree ;skin color;skin elasticity;lesion scope;vulvar microbiota;vaginal pH; | — |
Countries
China
Contacts
Jiangxi Maternal and Child Health Hospital