Lichen SclerosusNCT03419377
Lichen Sclerosus - the Influence on Quality of Life
A study of Lichen Sclerosus, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2018to 22 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Lichen Sclerosus
- Age over 18 years
Who cannot join
- Patients who does not understand or speak Danish
- Patients with a psychiatric diagnosis and can not follow the course
Trial locations and contacts
1 site in 1 country.
About this study
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.
Read the 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.
- Conditions
- Lichen Sclerosus
- Being tested
- Standard care and sexological counseling
- Keywords
- Treatment, Quality of Life, Sexology, Women
- Medical subject headings
- Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care and sexological counselingOther
6-8 sexological consultants in a period of six months
| Study group | Role | What they receive |
|---|---|---|
| Standard care and sexological counseling | Experimental | Standard care including gynecological examination and 6-8 sexological consultations. Receives: Other: Standard care and sexological counseling |
| Standard care | No intervention | Standard care including gynecological examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life in women with Lichen Sclerosus
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start4 Jan 2018
- Primary completion22 May 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dorte Melgaard Kristiansen, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419377
- Sponsor's protocol ID
- RHN_DMK_02
- Status last verified
- May 2020
- First submitted
- 26 Jan 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vittrup G, Westmark S, Riis J, Morup L, Heilesen T, Jensen D, Melgaard D. The Impact of Psychosexual Counseling in Women With Lichen Sclerosus: A Randomized Controlled Trial. J Low Genit Tract Dis. 2022 Jul 1;26(3):258-264. doi: 10.1097/LGT.0000000000000669. Epub 2022 Mar 25.
PubMed 35333024
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lichen Sclerosus - the Influence on Quality of Life
- ClinicalTrials.gov ID
- NCT03419377
- Acronym / sponsor ID
- RHN_DMK_02
- Conditions
- Lichen Sclerosus
- Keywords
- Treatment, Quality of Life, Sexology, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard care and sexological counseling | Experimental | Other: Standard care and sexological counselingStandard care including gynecological examination and 6-8 sexological consultations. |
| Standard care | No intervention | –Standard care including gynecological examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Lichen Sclerosus
- Age over 18 years
Key exclusion criteria (2 listed)
- Patients who does not understand or speak Danish
- Patients with a psychiatric diagnosis and can not follow the course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care and sexological counseling6-8 sexological consultants in a period of six months | Other | Standard care and sexological counseling |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 35333024Vittrup G, Westmark S, Riis J, Morup L, Heilesen T, Jensen D, Melgaard D. The Impact of Psychosexual Counseling in Women With Lichen Sclerosus: A Randomized Controlled Trial. J Low Genit Tract Dis. 2022 Jul 1;26(3):258-264. doi: 10.1097/LGT.0000000000000669. Epub 2022 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lichen Sclerosus, run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in women with Lichen Sclerosus (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.