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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Vulva Lichen Sclerosus

Treatments: Combination Product: 5-aminolevulinic acid (5-ALA) with red light illumination; Drug: Mometasone furoate (MMF) 0.1% ointment; Device: CO2 fractional laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05228483

XijingH-PF-20211102

Details and patient eligibility

About

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.

Full 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 photodynamic therapy.

For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive CO2 fractional laser before photodynamic therapy, while the other side will receive photodynamic therapy only.

Enrollment: 134 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Photodynamic treatment monotherapy or combined with CO2 fractional laser

Experimental group

Description:

For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive 5-aminolevulinic acid (5-ALA) with a red light illumination(80mW/cm2, and 120J/ cm2); while the other side will receive CO2 fractional laser(parameter: 20mm \*20mm, spot coverage rate 10%, and 18-25mJ/cm2) before photodynamic therapy. Treating area should cover 0.5cm beyond the visible boundary of the lesion. In total 6 therapies will be given for each patient, with 14±3d intervals.

Treatment:

Combination Product: 5-aminolevulinic acid (5-ALA) with red light illumination

Device: CO2 fractional laser

Mometasone furoate cream

Active Comparator group

Description:

Mometasone furoate cream (0.1%) for topical application, frequency: once daily, 5 days/week, for the first month; once every other day, for the second month; twice a week for the third month; the area of application should cover 0.5cm beyond the visible boundary of the lesion.

Treatment:

Drug: Mometasone furoate (MMF) 0.1% ointment