NCT05060224

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2.5 years

First QC Date

September 16, 2021

Last Update Submit

September 28, 2021

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of life, scale

    Danish health-related quality of life tool

    up to 10 weeks

Study Arms (1)

Low Level Laser

EXPERIMENTAL

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

Interventions

EasyLaser: Low Level Laser therapyDEVICE
Low Level Laser

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • History of vulvar intraepithelial neoplasi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Annemette Lykkebo, MD

    Sygehus Lillebælt, Kolding.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 29, 2021

Study Start

January 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Not planned.