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

NCT ID: NCT05228483

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2024-06-30

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 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.

Conditions

Vulva Lichen Sclerosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Photodynamic treatment monotherapy or combined with CO2 fractional laser

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.

Group Type: EXPERIMENTAL

CO2 fractional laser

Intervention Type: DEVICE

CO2 fraction laser

5-aminolevulinic acid (5-ALA) with red light illumination

Intervention Type: COMBINATION_PRODUCT

5-aminolevulinic acid (5-ALA) is a photosensitizing agent which can induce photochemical reactions in tissues in response to an appropriate wavelength of light (red light 630-635nm).

Mometasone furoate cream

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.

Group Type: ACTIVE_COMPARATOR

Mometasone furoate (MMF) 0.1% ointment

Intervention Type: DRUG

0.1% Mometasone furoate ointment is a potent steroid and has been proven to result as efficacious and well tolerated as clobetasol propionate which represent the recomended first-line treatment of vulvar lichen sclerosus.

Interventions

CO2 fractional laser

CO2 fraction laser

Intervention Type: DEVICE

5-aminolevulinic acid (5-ALA) with red light illumination

5-aminolevulinic acid (5-ALA) is a photosensitizing agent which can induce photochemical reactions in tissues in response to an appropriate wavelength of light (red light 630-635nm).

Intervention Type: COMBINATION_PRODUCT

Mometasone furoate (MMF) 0.1% ointment

0.1% Mometasone furoate ointment is a potent steroid and has been proven to result as efficacious and well tolerated as clobetasol propionate which represent the recomended first-line treatment of vulvar lichen sclerosus.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guannan Zhu

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Locations

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guannan Zhu

Role: CONTACT

to_rain77@163.com

+8615191881772

Facility Contacts

Gang Wang

Role: primary

+8684775401

Other Identifiers

XijingH-PF-20211102

Identifier Type: -

Identifier Source: org_study_id