Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laser Treatment for Vulvar Lichen Sclerosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134494
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
Sciton
Information provided by (Responsible Party):
Roger Lefevre, Beth Israel Deaconess Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Vulvar Lichen Sclerosus Device: Ablative Fractional 2940 nm Laser Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of 30 patients with biopsy-proven Lichen sclerosus will be treated on a monthly basis for 3 months. Biopsy to be repeated at month #6. The biopsy from before treatment will be compared with biopsies after treatment.
Masking: None (Open Label)
Masking Description: No masking will be used as all patients will receive the treatment.
Primary Purpose: Treatment
Official Title: Effectiveness of Ablative Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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˚.




Primary Outcome Measures :
  1. Change in histology and depth of disease from baseline to three months after the last laser treatment [ Time Frame: From enrollment to 9 month follow up visit ]
    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.


Secondary Outcome Measures :
  1. Change in symptoms and quality of life using the Vulvovaginal Symptom Questionnaire (VSQ) [ Time Frame: From enrollment to 9 month follow up visit ]

    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


  2. Change in symptoms using the Patient Global Impression Scale of Change (PGIC) [ Time Frame: From enrollment to 9 month follow up visit ]

    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. Change in symptom severity using the Patient Global Impression Scale of Severity (PGIS) [ Time Frame: From enrollment to 9 month follow up visit ]

    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


  4. Vulvar lichen sclerosus improvement as assessed using photographs [ Time Frame: From enrollment to 9 month follow up visit ]
    Photographs will be rated by observers blinded to whether a photo is before or after treatment

  5. Satisfaction with treatment using a participant satisfaction questionnaire [ Time Frame: From enrollment to 9 month follow up visit ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134494


Contacts
Layout table for location contacts
Contact: Roger Lefevre, MD 617-667-4070 rlefevre@bidmc.harvard.edu
Contact: Michele Hacker, MpH, ScD 617-667-2933 mhacker@bidmc.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
BIDMC Recruiting
Boston, Massachusetts, United States, 02115
Contact: Roger Lefevre, MD       rlefevre@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Sciton
Investigators
Layout table for investigator information
Principal Investigator: Roger Lefevre, MD Beth Israel Deaconess Medical Center
Layout table for additonal information
Responsible Party: Roger Lefevre, Instructor in Obstetrics, Gynecology and Reproductive Biology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04134494    
Other Study ID Numbers: 2019P000344
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by Roger Lefevre, Beth Israel Deaconess Medical Center:
Massachusetts residents
Additional relevant MeSH terms:
Layout table for MeSH terms
Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases