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NCT05467046Completed

Clinical Relevance of Scratching and Sleep in Atopic Dermatitis

Source: ClinicalTrials.gov · Last updated 3 Apr 2024

Brief summary (registry, in English)

Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice. In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.

Status (registry)
Completed
Study type
Observational
Enrollment
16 (actual)
First submitted
7 Jul 2022
Start date
3 Aug 2022
Primary completion date
30 Sept 2023
Lead sponsor
Philips Clinical & Medical Affairs Global
NCT number
NCT05467046

What you commit to

  • Study type: Observational
  • Participants enrolled: 16
  • From 3 Aug 2022 to the primary completion date, 30 Sept 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Irregular or affected sleep/wake pattern due to causes other than AD. (For example: medical conditions like sleep-apnea or primary insomnia, concomitant medication affecting sleep, alternating shift workers or AD-patients with young infants.)
  • Pregnant persons will not be considered for this study (during pregnancy, the treatment with advanced systemic treatment is not always possible)

Other illness

  • Patients with neurological disease (e.g., Parkinson's Disease) or physical disability affecting one or both hands, wrist and/or arms.
  • Cognitively impaired (diagnosis of cognitive impairment in medical file)
  • If a patient is not allowed to visit the hospital due to the prevailing COVID-19 restrictions. (If COVID-19 restrictions indicate that it is not allowed to visit the hospital for example when having a positive COVID-19 test, then the patient cannot be included in the study, because it cannot comply with the BioDay study protocol, and thereby indirectly also not with the AD-study protocol).
    • For dermatology HCPs the eligibility criteria are:

Other

  • Unable to understand instructions
  • Expected participation of less than 5 weeks
  • Travelling or holiday, for 1 night or more, outside the Netherlands during participation in the study.
  • Eczema lesions on one or both wrists at study recruitment
  • Having a tattoo on the upper side of one or both wrists. (Tattoos in the wrist area can cause inaccurate measurements.)
  • Institutionalized patients (e.g., care home residents)
  • Prisoners (general inmates of prisons or other state institutions)
  • Philips research employees
  • Study site employees or any other research team member involved directly or indirectly in the conduct of the clinical study
  • Unable or unwilling to attend focus group
  • Philips Research employees

Who the study is looking for

  • Patient has signed informed consent for the BioDay registry and is enrolled in the BioDay registry.
  • Patient has a diagnosis of moderate to severe Atopic Dermatitis, and therefore will be treated with advanced systemic treatment in daily practice according to the Dutch AD guideline (after treatment failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).
  • Patient has no concomitant immunosuppressive therapy at baseline
  • Age between 18 and 65 years old (18 years ≤ Age ≤ 65 years).
  • Intact skin at both wrists (definition of intact skin: Skin in which there are no breaks, scrapes, cuts, or abnormal openings that allow pathogens to enter).
  • Willing and able to provide written informed consent and participate in study procedures.
  • Able to understand, read and write Dutch.
  • HCP is allowed to treat AD-patients
  • HCP is (trainee) dermatologist, (trainee) physician, (trainee) research-physician, (trainee) nurse practitioner, (trainee) physician assistant or similar, working in the field of dermatology
  • HCP has (digitally) signed consent form for the focus group
  • HCP works in a hospital that is a member of the BioDay consortium.

Criteria the registry did not label

  • For Atopic Dermatitis patients the eligibility criteria are:

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.