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Lichen Sclerosus - the Influence on Quality of Life

Lichen Sclerosus - the Influence on Quality of Life

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03419377
Enrollment
158
Registered
2018-02-01
Start date
2018-01-04
Completion date
2020-05-22
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lichen Sclerosus

Keywords

Treatment, Quality of Life, Sexology, Women

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.

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

OTHERStandard care and sexological counseling

6-8 sexological consultants in a period of six months

Sponsors

Regionshospital Nordjylland
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life in women with Lichen SclerosusSix monthsChange 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026