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

Not Applicable

• Conditions: Vulva Lichen Sclerosus
• Interventions: Device: CO2 fractional laser; Drug: Mometasone furoate (MMF) 0.1% ointment; Combination Product: 5-aminolevulinic acid (5-ALA) with red light illumination

• Registration Number: NCT05228483
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-23
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08
• Primary Completion: 2023-11-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photodynamic treatment monotherapy or combined with CO2 fractional laser	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.
Mometasone furoate cream	Mometasone furoate (MMF) 0.1% ointment	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.
Photodynamic treatment monotherapy or combined with CO2 fractional laser	5-aminolevulinic acid (5-ALA) with red light illumination	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.

Primary Outcome Measures

Name	Time	Method
Global Subjective Score 75（GSS75） rate	2 weeks after the final treatment	GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable). GSS75 rate is the rate of patients achieving GSS75.

Secondary Outcome Measures

Name	Time	Method
Lichen Sclerosus Area （LSA）	2 weeks, 12 weeks, 6 months, 12months after the final treatment	The improvement of lichen sclerosus area from baseline by photograph documents with a standard scale
Recurrence rate	6 months, 12 months after the final treatment	Recurrence rate: the number of patients relapse/the number of patients who completed all treatment. Relapse is defined as an increase of 1 point in any of the six indicators of GOS, or an increase of ≥ 3 points in any of the GSS, or an increase of 1 point in any of the QOL compared with that at the 2-week visit after the final treatment.
Global Subjective Score 75（GSS75）	12 weeks after the final treatment	GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable)
Dermoscope Area Score （DAS）	2 weeks, 12 weeks, 6 months, 12 months after the final treatment	Dermoscope assessment of vessel morphology, bright white or white- yellowish structureless areas, shiny white streaks, purple dots, peppering blue-gray dots, erosions, and rose petal sign ( 0 = absent, 1 = mild, 2 = moderate, 3 = severe).
incidence of adverse events	up to 12 months	incidence of adverse events
Global Objective Score（GOS）	2 weeks, 12 weeks, 6 months, 12 months after the final treatment	Sum of scores in 6 aspects: Erythema, leukoplakia, hyperkeratosis, purpuric lesions, degree of sclerosis, scar-like atrophy (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Range : 0 - 18.
Quality of Life（QOL）	2 weeks, 12 weeks, 6 months, 12 months after the final treatment	Sum of scores of four indexes: dysuria, defecation difficulty, dysesthesia and dyspareunia (applicable patients) ( 0 = absent, 1 = mild, 2 = moderate, 3 = severe). Range: 0-12.

Trial Locations

Locations (1)

Dermatology Derpartment of Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China