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

NCT05228483 | Unknown

• 1 other identifier: XijingH-PF-20211102
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulva Lichen Sclerosus

Keywords

vulva lichen sclerosus; female; CO2 Fractional Laser; Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• Global Subjective Score 75（GSS75） rate

  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.

  2 weeks after the final treatment

Secondary Outcomes (7)

• Recurrence rate

  6 months, 12 months after the final treatment

• Global Subjective Score 75（GSS75）

  12 weeks after the final treatment

• Global Objective Score（GOS）

  2 weeks, 12 weeks, 6 months, 12 months after the final treatment

• Lichen Sclerosus Area （LSA）

  2 weeks, 12 weeks, 6 months, 12months after the final treatment

• Quality of Life（QOL）

  2 weeks, 12 weeks, 6 months, 12 months after the final treatment

Study Arms (2)

Photodynamic treatment monotherapy or combined with CO2 fractional laser

EXPERIMENTAL

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.

Device: CO2 fractional laser; Combination Product: 5-aminolevulinic acid (5-ALA) with red light illumination

Mometasone furoate cream

ACTIVE COMPARATOR

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.

Drug: Mometasone furoate (MMF) 0.1% ointment

Interventions

CO2 fractional laser DEVICE

CO2 fraction laser

Photodynamic treatment monotherapy or combined with CO2 fractional laser

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

Photodynamic treatment monotherapy or combined with CO2 fractional laser

Mometasone furoate (MMF) 0.1% ointment 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.

Mometasone furoate cream

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 (inclusive), female patients;
• present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination;
• Volunteer to participate in this study and sign an informed consent form.

You may not qualify if:

• Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.;
• Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.;
• Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis;
• People with porphyria or porphyria allergy;
• Suffer from psychiatric diseases, such as schizophrenia, etc.;
• Those who are undergoing systemic treatment due to malignant tumor diseases, such as cervical cancer;
• It is confirmed by laboratory pathogenic screening to have syphilis, HIV, and other sexually transmitted diseases or viral hepatitis;
• Patients with current bacterial or fungal infections in the anus and genitals;
• Women of childbearing age who have pregnancy plans, are pregnant, or are breastfeeding during the observation period of this study;
• Patients who are systematically using glucocorticoids, immunosuppressants, and anticoagulants;
• Use glucocorticoids for topical or local injection and calcineurin inhibitors for topical use within 4 weeks;
• Those who are allergic to 5-aminolevulinic acid or its base, mometasone furoate or its base;
• Other situations that the investigator considers inappropriate to participate in the clinical study.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Aminolevulinic Acid; Mometasone Furoate; Ointments

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Guannan Zhu

  Dermatology Derpartment of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guannan Zhu

CONTACT

+8615191881772; to_rain77@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 8, 2022
• Study Start: November 23, 2021
• Primary Completion: November 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 8, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)