Laser Treatment for Vulvar Lichen Sclerosus

Effectiveness of Ablative Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus

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.

Study Overview

• Status: Terminated
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Device: Ablative Fractional 2940 nm Laser

Detailed Description

This will be a non-randomized, open-label, prospective study. Participants will be recruited in general and subspecialty obstetrics 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. The investigators will also 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.
  • The investigators will take photographs of the affected area.

• Follow-up visit 2, month 6

  • Participants will be asked to complete questionnaires to assess outcomes.
  • The investigators 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.
  • The investigators will take photographs of the affected area.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • BIDMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

We are currently recruiting Massachusetts residents only due to COVID-19.

Inclusion Criteria:

• Female
• Aged 18 years old or older
• Biopsy-proven active vulvar lichen sclerosus
• Characteristic changes of vulvar lichen sclerosus on gynecological exam

• Self-reported indication of one or more of the following symptoms of lichen sclerosus

  • Dryness
  • Itching
  • Burning
  • Bleeding
  • Blistering
  • Soreness
  • Easily bruises
  • Easily tears
  • Ulcerated lesions
  • Painful intercourse
• Ability to complete questionnaires in English
• Written, informed consent
• Willing and able to logistically follow schedule of treatments and follow-up visits

Exclusion Criteria:

• Receiving systemic immunosuppressant's (e.g. corticosteroids) within 4 weeks of enrollment
• Use of topical vulvar steroid-containing creams at the affected area within 4 weeks of enrollment
• Immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome)
• History of uncontrolled malignant disease
• Additional genital skin disease
• Known allergy or intolerance to topical anesthesia
• Known history of connective tissue disease
• Known propensity for keloid formations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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

Device: Ablative Fractional 2940 nm Laser; 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˚.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment	The baseline depth of lichen sclerosus will be based on the results of the clinical biopsy performed before study participation. The investigators will use the study biopsy collected at the follow-up visit three months after the last treatment to determine resolution of disease or, if disease persists, to what depth. The biopsies will therefore serve as an objective means to determine effective treatment of disease.	From enrollment to 3 months after the last laser treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptoms and Quality of Life Using the Vulvovaginal Symptom Questionnaire (VSQ)	The VSQ is a 21-item written questionnaire with four scales: symptoms, emotions, life-impact, and sexual impact. Each item is assessed with yes or no questions. If a participant answers no, they receive a score of 0, and if the participant answers yes, they receive a score of 1 for each question. The results are added to a composite score. Minimum score (better outcome): 0 Maximum score (worse outcome): 21	From enrollment to 3 months after last laser treatment
Change in Symptoms Using the Patient Global Impression Scale of Change (PGIC)	The PGIC is a written questionnaire to assess change in status or symptoms over time. Patients can say that their symptoms are: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6) or very much worse (7). Minimum score (better outcome): 1 Maximum score (worse outcome): 7	3 months after last laser treatment
Change in Symptom Severity Using the Patient Global Impression Scale of Severity (PGIS)	The PGIs is a written questionnaire to assess current status or symptoms. Patients can say that their symptoms are: normal (1), mild (2), moderate (3), or severe (4). Minimum score (better outcome): 1 Maximum score (worse outcome): 4	From enrollment to 3 months after last laser treatment
Satisfaction With Treatment Using a Participant Satisfaction Questionnaire	Using a written questionnaire, patients will be asked how satisfied they were with the treatment. They can choose that they are extremely satisfied (1), somewhat satisfied (2), neither satisfied nor dissatisfied (3), somewhat dissatisfied (4), or extremely dissatisfied (5). Minimum score (better outcome): 1 Maximum score (worse outcome): 5	3 months after last laser treatment

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Sciton
• Investigators: Principal Investigator: Roger Lefevre, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Massachusetts residents
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: 2019P000344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes