Vulvar Lichen SclerosusNCT03686800
The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
A study testing Rivelin® plain patches in people with Vulvar Lichen Sclerosus, run by Dermtreat at 1 site in Denmark.
Trial summary
This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Rivelin® plain patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Sep 2018to 15 Nov 2018
- 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
- Women (≥ 18 years) diagnosed with VLS
- Has received written and oral study information
- Has given her written consent to study participation
Who cannot join
- Pregnant
- Menstruating at the time of patch application
- Unable to communicate clearly with the examining doctors
- Under the guardianship of another person or institution
Trial locations and contacts
1 site in 1 country.
About this study
This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS).
Read the detailed description
The Rivelin® plain patch works by forming a protective barrier over a lesion, protecting it from further irritation and thus providing pain relief in much the same way as the adhesive pastes and films that are available to treat VLS. However, the adhesion/protection time of the Rivelin® plain patch is expected to be longer compared to current treatment with bioadhesive agents, thereby potentially increasing the pain free period for the subject.
This study is undertaken to gather information covering adhesion time and tolerability of the Rivelin® plain patch on areas affected by VLS. Since protecting a lesion with a physical barrier could reduce the sensation of pain caused by normal function, this investigation will also explore subject experienced pain and/or symptom relief during use of the patch for further development.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Rivelin® plain patches
- Keywords
- VLS
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivelin® plain patchesDevice
The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients
| Study group | Role | What they receive |
|---|---|---|
| Rivelin® plain patches | Experimental | This is an open label study with the objectives to establish information on adhesion time, tolerability and usability of Rivelin® plain patches when applied to VLS lesions. Furthermore, the design of the Rivelin® plain patch will also be evaluated. Receives: Device: Rivelin® plain patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion time for Rivelin® plain patches
The proportion of successful applications of Rivelin® plain patches (defined as an adhesion time ≥ 30 min); separate summaries for morning and evening applications
Measured: 2 days
Secondary outcomes (5)
Adverse Events
Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation
Measured: 2 days
Ability to apply patches correctly
Study staff reported observation on subject's ability to apply patches correctly
Measured: 2 days
Understanding of the Instructions for use leaflet
Subject reported outcome on the understanding of the Instructions for use leaflet
Measured: 2 days
Visual analogue scale (VAS) scores
Visual analogue scale (VAS) scores for discomfort, pain, itching and burning prior to applying the first patch, at 2 hours after application (or when the first patch detaches) and on day 2
Measured: 2 days
Optimising the design of the patch
Subject responses towards optimising the design of the patch
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start25 Sep 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermtreat
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Larix A/S
- Responsible party
- Sponsor
- Investigators
- Gregor B.E. Jemec, MD, Principal investigator, Zealand University Hospital, Dermatology dpt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686800
- Sponsor's protocol ID
- DT-001-R-002
- Status last verified
- Mar 2019
- First submitted
- 24 Sep 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
- ClinicalTrials.gov ID
- NCT03686800
- Acronym / sponsor ID
- DT-001-R-002
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- VLS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- DermtreatIndustry (pharma, biotech, devices)
- Collaborators
- Larix A/S
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 27 Sep 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.
This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS).
Detailed description
The Rivelin® plain patch works by forming a protective barrier over a lesion, protecting it from further irritation and thus providing pain relief in much the same way as the adhesive pastes and films that are available to treat VLS. However, the adhesion/protection time of the Rivelin® plain patch is expected to be longer compared to current treatment with bioadhesive agents, thereby potentially increasing the pain free period for the subject.
This study is undertaken to gather information covering adhesion time and tolerability of the Rivelin® plain patch on areas affected by VLS. Since protecting a lesion with a physical barrier could reduce the sensation of pain caused by normal function, this investigation will also explore subject experienced pain and/or symptom relief during use of the patch for further development.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivelin® plain patches | Experimental | Device: Rivelin® plain patchesThis is an open label study with the objectives to establish information on adhesion time, tolerability and usability of Rivelin® plain patches when applied to VLS lesions. Furthermore, the design of the Rivelin® plain patch will also be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women (≥ 18 years) diagnosed with VLS
- Has received written and oral study information
- Has given her written consent to study participation
Key exclusion criteria (4 listed)
- Pregnant
- Menstruating at the time of patch application
- Unable to communicate clearly with the examining doctors
- Under the guardianship of another person or institution
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 |
|---|---|---|
| Rivelin® plain patchesThe comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients | Device | Rivelin® plain patches |
Primary outcome
Adhesion time for Rivelin® plain patches
Time frame: 2 days
The proportion of successful applications of Rivelin® plain patches (defined as an adhesion time ≥ 30 min); separate summaries for morning and evening applications
5 secondary outcomes
Adverse Events
Time frame: 2 days
Ability to apply patches correctly
Time frame: 2 days
Understanding of the Instructions for use leaflet
Time frame: 2 days
Visual analogue scale (VAS) scores
Time frame: 2 days
Optimising the design of the patch
Time frame: 2 days
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 19 Mar 2019.
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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.
Gregor B.E. Jemec, MD principal investigator
Zealand University Hospital, Dermatology dpt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivelin® plain patches in people with Vulvar Lichen Sclerosus, run by Dermtreat 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 3 inclusion and 4 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 19 Mar 2019. 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?
Adhesion time for Rivelin® plain patches (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2019.