Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 25 for:    "Lichen Sclerosus"

The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686800
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Larix A/S
Information provided by (Responsible Party):
Dermtreat

Brief 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).

Condition or disease Intervention/treatment Phase
Vulvar Lichen Sclerosus Device: Rivelin® plain patches Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
Actual Study Start Date : September 25, 2018
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Rivelin® plain patches
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.
Device: Rivelin® plain patches
The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 days ]
    Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation

  2. Ability to apply patches correctly [ Time Frame: 2 days ]
    Study staff reported observation on subject's ability to apply patches correctly

  3. Understanding of the Instructions for use leaflet [ Time Frame: 2 days ]
    Subject reported outcome on the understanding of the Instructions for use leaflet

  4. Visual analogue scale (VAS) scores [ Time Frame: 2 days ]
    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

  5. Optimising the design of the patch [ Time Frame: 2 days ]
    Subject responses towards optimising the design of the patch



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Women (≥ 18 years) diagnosed with VLS
  2. Has received written and oral study information
  3. Has given her written consent to study participation

Exclusion Criteria:

  1. Pregnant
  2. Menstruating at the time of patch application
  3. Unable to communicate clearly with the examining doctors
  4. Under the guardianship of another person or institution

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 ClinicalTrials.gov identifier (NCT number): NCT03686800


Locations
Layout table for location information
Denmark
Zealand University Hospital, Dermatology dpt.
Roskilde, Denmark, 4000
Sponsors and Collaborators
Dermtreat
Larix A/S
Investigators
Layout table for investigator information
Principal Investigator: Gregor B.E. Jemec, MD Zealand University Hospital, Dermatology dpt.

Layout table for additonal information
Responsible Party: Dermtreat
ClinicalTrials.gov Identifier: NCT03686800     History of Changes
Other Study ID Numbers: DT-001-R-002
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dermtreat:
VLS
Additional relevant MeSH terms:
Layout table for MeSH terms
Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases
Genital Diseases, Female