Lichen Sclerosus - the Influence on Quality of Life

A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.

Completed

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Key information

Conditions

Lichen Sclerosus Lichen Sclerosus et Atrophicus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vendsyssel Hospital

Hjørring, 9800, Denmark

About this study

The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with Lichen Sclerosus
Age over 18 years

Exclusion criteria

Patients who does not understand or speak Danish
Patients with a psychiatric diagnosis and can not follow the course

Treatment and study plan

Standard care and sexological counseling

Other

6-8 sexological consultants in a period of six months

Primary outcomes

Quality of Life in women with Lichen Sclerosus

Time frame: Six months

Change in EuroQol five dimension (EQ-5D) score. The descriptive system comprises 5 dimensions (mobili-ty, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.

Sponsors and collaborators

Lead sponsor

Regionshospital Nordjylland

Other Gov

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Feb 1, 2018
Registry last updated: May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed