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Trial record 12 of 25 for:    "Lichen Sclerosus"

Lichen Sclerosus - the Influence on Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03419377
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Dorte Melgaard Kristiansen, Vendsyssel Hospital

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

Condition or disease Intervention/treatment Phase
Lichen Sclerosus Other: Standard care and sexological counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lichen Sclerosus - the Influence on Quality of Life
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Standard care and sexological counseling
Standard care including gynecological examination and 6-8 sexological consultations.
Other: Standard care and sexological counseling
6-8 sexological consultants in a period of six months

No Intervention: Standard care
Standard care including gynecological examination.

Primary Outcome Measures :
  1. Quality of Life [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03419377

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Contact: Dorte Melgaard, phd +4526281086
Contact: Dorthe S Brønnum, MSc +4597641380

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Vendsyssel Hospital Recruiting
Hjørring, Denmark, 9800
Contact: Dorte Melgaard, phd    +4526281086   
Principal Investigator: Dorte Melgaard, phd         
Sponsors and Collaborators
Vendsyssel Hospital

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Responsible Party: Dorte Melgaard Kristiansen, Research Coordinator, Vendsyssel Hospital Identifier: NCT03419377     History of Changes
Other Study ID Numbers: RHN_DMK_02
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dorte Melgaard Kristiansen, Vendsyssel Hospital:
Quality of Life
Additional relevant MeSH terms:
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Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases