Lichen Sclerosus – the Influence on Quality of Life

Overview

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

Full Title of Study: “Lichen Sclerosus – the Influence on Quality of Life”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 22, 2020

Detailed Description

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.

Interventions

  • Other: Standard care and sexological counseling
    • 6-8 sexological consultants in a period of six months

Arms, Groups and Cohorts

  • Experimental: Standard care and sexological counseling
    • Standard care including gynecological examination and 6-8 sexological consultations.
  • No Intervention: Standard care
    • Standard care including gynecological examination.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vendsyssel Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dorte Melgaard Kristiansen, Research Coordinator – Vendsyssel Hospital

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