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Improvement of vulvar skin dysbiosis increases the efficacy of vulvar lichen sclerosus treatment

Improvement of vulvar skin dysbiosis increases the efficacy of vulvar lichen sclerosus treatment

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090750
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-09-15
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vulvar lichen sclerosus

Interventions

Healthy control group:None
Vulvar lichen sclerosus group:None
Vulvar lichen sclerosus + glucocorticoid group:topical glucocorticoid
Vulvar lichen sclerosus+glucocorticoid+postbiotics group:topical glucocorticoid and postbiotic

Sponsors

Jiangxi Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

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

MeasureTime frame
pruritus degree ;skin color;skin elasticity;lesion scope;vulvar microbiota;vaginal pH;

Countries

China

Contacts

Public ContactHong Liao

Jiangxi Maternal and Child Health Hospital

524004446@qq.com+86 136 9800 7205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026