Clinical trial NCT05228483: Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus
Official title: Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulva Lichen Sclerosus
Keywords: vulva lichen sclerosus
female
CO2 Fractional Laser
Photodynamic Therapy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Global Subjective Score 75（GSS75） rate
timeFrame: 2 weeks after the final treatment
Secondary outcomes:
measure: Recurrence rate
timeFrame: 6 months, 12 months after the final treatment
measure: Global Subjective Score 75（GSS75）
timeFrame: 12 weeks after the final treatment
measure: Global Objective Score（GOS）
timeFrame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
measure: Lichen Sclerosus Area （LSA）
timeFrame: 2 weeks, 12 weeks, 6 months, 12months after the final treatment
measure: Quality of Life（QOL）
timeFrame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
measure: Dermoscope Area Score （DAS）
timeFrame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
measure: incidence of adverse events
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dermatology Derpartment of Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Guannan Zhu
role: PRINCIPAL_INVESTIGATOR
References: