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

China134 participantsStarted 2021-11-23

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Global Subjective Score 75（GSS75） rate

Timeframe: 2 weeks after the final treatment

Trial details

NCT IDNCT05228483

SponsorXijing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-30

Contact for this trial

Guannan Zhu

+8615191881772 to_rain77@163.com

View on ClinicalTrials.gov More Vulva Lichen Sclerosus trials