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

NCT05228483 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2022-02-08

No results posted yet for this study

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

Interventions

DEVICE

CO2 fractional laser

CO2 fraction laser

COMBINATION_PRODUCT

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).

DRUG

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Guannan Zhu · Dermatology Derpartment of Xijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-11-30
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228483 on ClinicalTrials.gov