Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2024-07-30

Brief Summary

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The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.

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Detailed Description

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Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.

Conditions

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Chronic Skin Disease Vulvar Lichen Sclerosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, active-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser

dual Fotona laser treatment (Nd:YAG and Er:YAG)

Group Type EXPERIMENTAL

FotonaSmooth SP® Spectro laser device

Intervention Type DEVICE

dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.

Topical steroid

clobetasol propionate 0.05% cream

Group Type ACTIVE_COMPARATOR

Clobetasol propionate 0.05% ointment

Intervention Type DRUG

6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months)

Interventions

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FotonaSmooth SP® Spectro laser device

dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.

Intervention Type DEVICE

Clobetasol propionate 0.05% ointment

6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months)

Intervention Type DRUG

Other Intervention Names

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Laser therapy Local steroid therapy

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of vulvar lichen sclerosus
* Clinical LS score ≥ 4

Exclusion Criteria

* Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
* \< 3 months since start of vaginal estrogen treatment
* Malignant disease as the cause of the vulval symptoms
* BMI \> 35 kg/m²
* Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
* Presence of contraindications for the laser treatment or topical steroid treatment

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No