Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Aminolevulinic Acid; Mometasone Furoate

Criteria

Inclusion Criteria:

1. Age 18-60 (inclusive), female patients;

2. present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination;

3. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.;

2. Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.;

3. Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis;

4. People with porphyria or porphyria allergy;

5. Suffer from psychiatric diseases, such as schizophrenia, etc.;

6. Those who are undergoing systemic treatment due to malignant tumor diseases, such as cervical cancer;

7. It is confirmed by laboratory pathogenic screening to have syphilis, HIV, and other sexually transmitted diseases or viral hepatitis;

8. Patients with current bacterial or fungal infections in the anus and genitals;

9. Women of childbearing age who have pregnancy plans, are pregnant, or are breastfeeding during the observation period of this study;

10. Patients who are systematically using glucocorticoids, immunosuppressants, and anticoagulants;

11. Use glucocorticoids for topical or local injection and calcineurin inhibitors for topical use within 4 weeks;

12. Those who are allergic to 5-aminolevulinic acid or its base, mometasone furoate or its base;

13. Other situations that the investigator considers inappropriate to participate in the clinical study.