Status:
UNKNOWN
Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus
Lead Sponsor:
Xijing Hospital
Conditions:
Vulva Lichen Sclerosus
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.
Detailed Description
This is a randomized, open-labeled, assessor-blind, parallel control study. 134 enrolled patients will be randomized to apply either topical 0.1% corticosteroid mometasone furoate(MMF) ointment or pho...
Eligibility Criteria
Inclusion
- Age 18-60 (inclusive), female patients;
- present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination;
- Volunteer to participate in this study and sign an informed consent form.
Exclusion
- Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.;
- Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.;
- Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis;
- People with porphyria or porphyria allergy;
- Suffer from psychiatric diseases, such as schizophrenia, etc.;
- Those who are undergoing systemic treatment due to malignant tumor diseases, such as cervical cancer;
- It is confirmed by laboratory pathogenic screening to have syphilis, HIV, and other sexually transmitted diseases or viral hepatitis;
- Patients with current bacterial or fungal infections in the anus and genitals;
- Women of childbearing age who have pregnancy plans, are pregnant, or are breastfeeding during the observation period of this study;
- Patients who are systematically using glucocorticoids, immunosuppressants, and anticoagulants;
- Use glucocorticoids for topical or local injection and calcineurin inhibitors for topical use within 4 weeks;
- Those who are allergic to 5-aminolevulinic acid or its base, mometasone furoate or its base;
- Other situations that the investigator considers inappropriate to participate in the clinical study.
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05228483
Start Date
November 23 2021
End Date
June 30 2024
Last Update
February 8 2022
Active Locations (1)
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1
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, China, 710032