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

Sponsor

Kolding Sygehus (Other)

Overall Status

Completed

CT.gov ID

NCT05060224

Collaborator

(none)

100

Enrollment

Arm

Actual Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	Device: EasyLaser: Low Level Laser therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Level Laser 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.	Device: EasyLaser: Low Level Laser therapy

Arm

Intervention/Treatment

Experimental: Low Level Laser

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.

Device: EasyLaser: Low Level Laser therapy

Outcome Measures

Primary Outcome Measures

Quality of life, scale [up to 10 weeks]
Danish health-related quality of life tool

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kolding Sygehus

Investigators

Study Chair: Annemette Lykkebo, MD, Sygehus Lillebælt, Kolding.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kolding Sygehus

ClinicalTrials.gov Identifier:

NCT05060224

Other Study ID Numbers:

18/27286

First Posted:

Sep 29, 2021

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vulvar Lichen Sclerosus

Lichen Sclerosus et Atrophicus

Study Results

No Results Posted as of Oct 6, 2021