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
About this trial
This is an interventional treatment trial for Quality of Life
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
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
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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