Topics

Laser Treatment for Vulvar Lichen Sclerosus

2019-10-28 13:57:24 | BioPortfolio

Summary

The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus.

Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment.

Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus.

The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.

Description

This will be a non-randomized, open-label, prospective study. Participants will be recruited in general and subspecialty obstetric and gynecology clinics. Participants who meet all eligibility criteria, including providing written informed consent, will have three treatment visits and three follow-up visits in an outpatient setting. Participants will not be charged for any treatments.

At each treatment visit, participants will be asked to complete questionnaires to assess their symptoms. We also will take photographs of the affected area at each treatment visit. Photographs will include only the area of lichen sclerosus, such that individuals cannot be identified in the photographs. Participant photographs will be taken using the BIDMC PhotoConsult iOS application that allows providers to upload photographs to a patient's online medical record through a secure application.

Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart.

Prior to receiving treatment, topical 4% lidocaine anesthetic will be applied to the affected area for 20-30 minutes and then wiped away. The treatment area will be cleaned and dried of any moisture prior to treatment. The disinfected standoff with sapphire plate will then be applied to the ProFractional hand piece. Based on the biopsy results, the appropriate ablation depth will be inputted with 11% treatment density selected. Each treatment will include two passes of the laser over the affected area.

- Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚.

- Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.

- Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.

Participants will return for follow-up visits at 1, 3, and 6 months (months 3, 6 and 9 of the study) following the third treatment.

- Follow-up visit 1, month 3

- Participants will be asked to complete questionnaires to assess outcomes.

- We will take photographs of the affected area.

- Follow-up visit 2, month 6

- Participants will be asked to complete questionnaires to assess outcomes.

- We will take photographs of the affected area.

- Biopsy of area with lichen sclerosus; the biopsy will be done the same way as the one that was done to diagnosis your lichen sclerosus

- Follow-up visit 6, month 9

- Participants will be asked to complete questionnaires to assess outcomes.

- We will take photographs of the affected area.

Study Design

Conditions

Vulvar Lichen Sclerosus

Intervention

Ablative Fractional 2940 nm Laser

Status

Not yet recruiting

Source

Beth Israel Deaconess Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-28T13:57:24-0400

Clinical Trials [1305 Associated Clinical Trials listed on BioPortfolio]

The CO2RE® System for Vulvar Lichen Sclerosus

Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in symptoms, clinical si...

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

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 ablat...

Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus

The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy and in vulvar lichen sclerosus by means of histological and immuno-histochemical characterizat...

Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis

Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. As measured by visual analogue scale (VAS) symptoms ...

MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cau...

PubMed Articles [2244 Associated PubMed Articles listed on BioPortfolio]

An arm-based network meta-analysis on treatments for vulvar lichen sclerosus and a call for development of core outcome sets: Treatment options for vulvar lichen sclerosus.

The purpose of the present systematic review is to evaluate the available medical treatments for vulvar lichen sclerosus, using an arm based network meta-analysis protocol.

The long-term clinical consequences of Juvenile Vulvar Lichen Sclerosus, a systematic review.

Vulvar lichen sclerosus (VLS) occurring in juveniles (children and adolescents) may have repercussions throughout life.

Vulvar Squamous Cell Carcinoma in a Patient With Vulvar Lichen Sclerosus.

Re-pigmentation of Hypopigmentation: Fractional Lasers vs Laser-Assisted Delivery of Bimatoprost vs Epidermal Melanocyte Harvesting System

Background: Hypopigmentation is a common cutaneous manifestation that frequently poses a therapeutic challenge for dermatologists. Current treatments have varying efficacies and rarely provide patient...

Pathophysiology, Clinical Manifestations, and Treatment of Lichen Sclerosus: a systematic review.

To elucidate current understanding on the pathophysiologic mechanism of genital lichen sclerosus (LS), urologic manifestations, and treatment options.

Medical and Biotech [MESH] Definitions

Atrophy and shriveling of the SKIN of the VULVA that is characterized by the whitish LICHEN SCLEROSUS appearance, inflammation, and PRURITUS.

A chronic inflammatory mucocutaneous disease usually affecting the female genitalia (VULVAR LICHEN SCLEROSUS) and BALANITIS XEROTICA OBLITERANS in males. It is also called white spot disease and Csillag's disease.

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

Inflammation of the vulvar vestibular region at the entrance of the VAGINA, generally involving surface mucosa and submucosal vestibular glands. It is characterized by ERYTHEMA and chronic recurrent pain in this area.

Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.

More From BioPortfolio on "Laser Treatment for Vulvar Lichen Sclerosus"

Quick Search

Relevant Topic

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...


Searches Linking to this Trial