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Low-Level Laser Therapy: an Efficient Supplement to Treatments of Vulvar Lichen Sclerosus to Improve Quality of Life

Primary Purpose

Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EasyLaser: Low Level Laser therapy
Sponsored by
Kolding Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed with lichen sclerosus either clinically or by histopathological verification
  • Age ≥ 18 years
  • No significant relief in symptoms despite of topical treatment with potent steroids or calcineurin inhibitors

Exclusion Criteria:

  • Age < 18 years
  • History of vulvar intraepithelial neoplasi

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Low Level Laser

    Arm Description

    EasyLaser: Low Level Laser 808 nm and 500 mW. The first four treatments where planned as two treatments per week. The remaining six treatments where planned as once a week.

    Outcomes

    Primary Outcome Measures

    Quality of life, scale
    Danish health-related quality of life tool

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2021
    Last Updated
    September 28, 2021
    Sponsor
    Kolding Sygehus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05060224
    Brief Title
    Low-Level Laser Therapy: an Efficient Supplement to Treatments of Vulvar Lichen Sclerosus to Improve Quality of Life
    Official Title
    Low-Level Laser Therapy: an Efficient Supplement to Treatments of Vulvar Lichen Sclerosus to Improve Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kolding Sygehus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objectives: The aim of this study was to investigate whether Low Level Laser therapy (LLLT) can improve the quality of life in women with Lichen Sclerosus (LS) and insufficient topical treatment. Methods: In a clinical trial study conducted between January 2016 and July 2018, the investigators included 100 women with LS with insufficient topical treatment. All participants received ten LLLT treatments (808 nm and 500 mW) over a period of 8 weeks. The first four treatments where planned as two treatments per week. The remaining six treatments where planned as once a week. The effect was monitored by a Danish health-related quality of life tool (HRQoL test).
    Detailed Description
    Hundred participants with LS were included in a clinical trial at Lillebaelt Hospital, Denmark in the period from 02.01.2016 to 08.01.2018. The participants were informed about the purpose of research and the fact that LLLT was not standard-of-care treatment in our out-patient clinic. All participants who declined to take part in the study received standard-of-care treatment (topical steroid or topical calcineurin inhibitors) according to Danish national guidelines. Participants enrolled in the study received both standard-of-care treatment and LLLT. The participants received 10 LLLT treatments of 808 nm and 500mW. Every treatment was with a duration of 10 minutes. The first four treatments where planned as two treatments per week. The remaining six treatments where planned as once a week due to logistic considerations. The participants received the LLLT treatment while lying in the same position as during a gynecological examination. The light waves were placed 10 centimeters from the anogenital area covering the symptomatic area. If the participants had symptoms from both the vulva and the area around the rectum, the light were replaced after 10 minutes of treatment making sure no area were treated twice. All patients were recommended to continue their topical treatment during the study period. A Danish health-related quality of life tool (DoloTest®) was used to evaluate the effect of the treatment. The HRQoL test is a validated Danish tool developed for pain patients. It is validated against the Medical Outcomes Study Short Form Surveys (SF36TM). The HRQoL test requires little time and is therefore easy to use in a clinical setting. It is composed of eight domains arranged in a radar plot; pain, problems sleeping, reduced social life, low spirit, reduced energy and physical strength, problems at work, problems with more strenuous physical activity, and problems with light physical activity. Starting with the domain pain the patient marks every domain horizontally moving clockwise and thereby creates a graphic illustration, which helps the physician and the participant to understand the impact of the condition. The larger the shaded area the more the patient feels affected. Every mark represents a score. The maximum score of the HRQoL test is the total sum of the eight domains multiplied by 100, the maximum score being 800. The participants completed the HRQoL test before first LLLT treatment and after the last treatment. A written informed consents was obtained from all patients enrolled in the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Level Laser
    Arm Type
    Experimental
    Arm Description
    EasyLaser: Low Level Laser 808 nm and 500 mW. The first four treatments where planned as two treatments per week. The remaining six treatments where planned as once a week.
    Intervention Type
    Device
    Intervention Name(s)
    EasyLaser: Low Level Laser therapy
    Primary Outcome Measure Information:
    Title
    Quality of life, scale
    Description
    Danish health-related quality of life tool
    Time Frame
    up to 10 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with lichen sclerosus either clinically or by histopathological verification Age ≥ 18 years No significant relief in symptoms despite of topical treatment with potent steroids or calcineurin inhibitors Exclusion Criteria: Age < 18 years History of vulvar intraepithelial neoplasi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Annemette Lykkebo, MD
    Organizational Affiliation
    Sygehus Lillebælt, Kolding.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Not planned.

    Learn more about this trial

    Low-Level Laser Therapy: an Efficient Supplement to Treatments of Vulvar Lichen Sclerosus to Improve Quality of Life

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