Atopic DermatitisNCT05137093
Scratching Validation Study
An observational study of Atopic Dermatitis, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Actigraphy Device
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2021to 1 Feb 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Healthy \& Atopic dermatitis subjects
Who may be able to join
- Be aged 18 to 75 years, inclusive
- Be willing and able to undergo a single night of actigraphy and video monitoring overnight in a laboratory
- Be willing and able to provide informed consent
- (patients only): Diagnosed with atopic dermatitis by a clinician, following the criteria listed in Table 1.
- (patients only): IGA score ≥ 2.
- (patients only): Willing and able to use only non-medicated topical therapy (i.e., bland emollient/moisturizer) for 7 days before the overnight visit.
- Participants should be in bed a minimum of 4 hours
Who cannot join
- Any acute and/or unstable illness or medical complication which, in the opinion of a clinician, could compromise data collection and/or interpretation
- Use of any over-the-counter, prescription, or recreational drugs that may induce sleep or pruritus within 24 hours prior to overnight monitoring
- Use of any over-the-counter or prescription treatment (systemic, or topical) that could affect the course of atopic dermatitis during the study period. Key medications are listed below:
- From 3 Months prior to overnight visit: Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor inhibitors, antiimmunoglobulin IgE antibodies, anti-CD20 antibodies, anti-interleukin-4 receptor)
- Has used systemic treatments that could affect AD within 30 days or 5 half- lives before the overnight visit. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and systemic corticosteroids)
- Phototherapy treatment, laser therapy, bleach baths, tanning booths or extended sun exposure that could affect disease severity or interfere with disease assessments within 30 days before the overnight visit.
Show all 27Show fewer
- Use within 21 days before the overnight visit: Topical corticosteroids that were classified as super-high potency (clobetasol propionate).
- Use within 14 days before the overnight visit: any other topical phosphodiesterase 4 (PDE4) inhibitor; Tacrolimus and pimecrolimus cream and/or ointment; Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone).
- From 7 days before the overnight visit:
- antibiotics
- antifungal or antivirus medications
- Antihistamines/anti-allergics: diphenhydramine, chlorpheniramine maleate, hydroxyzine)
- Topical phosphodiesterase 4 (PDE4) inhibitor
- Topical calcineurin inhibitors (tacrolimus and pimecrolimus cream and/or ointment)
- Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone)
- Any other topical therapy with active ingredients to treat AD or with additives that could affect AD (e.g., hyaluronic acid, urea, ceramide or filaggrin degradation products).
- Individuals clinically diagnosed with a sleep disorder who are NOT on a controlled treatment regime
- An Epworth Sleepiness Scale score of ≥11, indicating daytime hypersomnolence
- Previous diagnosis of a movement disorder, including but not limited to, restless legs syndrome, periodic limb movement disorder, Tourette's syndrome, tremor, or dystonia
- Commercial driver's license and/or high-risk occupation that could be impacted by the occurrence of daytime sleepiness
- Self-reported habitual sleep duration of <6 hours per night on average
- Shift worker, advanced/delayed circadian phase, and/or any other condition suggesting that the participant would be unable to sleep during overnight monitoring
- Self-reported pregnancy current or planned during the study
- Employee or spouse of an employee of company that designs, sells, or manufactures sleep related products and/or wearable devices (including Philips).
- (patients only): Any significant dermatological condition, other than atopic dermatitis, as determined by a clinician.
- (controls only): Any significant dermatological condition as determined by a clinician.
- Currently using medication for any skin disease/condition and could not, in the opinion of the investigator, tolerate restriction or discontinuation of the medication as required by the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Independent Validation Study of Nighttime Scratching Quantification With Actigraphy in Adults With Atopic Dermatitis
Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls.
Read the detailed description
The Philips scratching algorithm has been cross-validated against the gold-standard assessment of scratching. The algorithm has been used in many drug development trials, occasionally as a means of generating secondary endpoints, but most often as a means of generating exploratory endpoints. The purpose of the proposed study is therefore to validate the data generated by the scratching study compared to the gold-standard video-assessment of scratching, in an independent sample of adults with atopic dermatitis and age- and sex-matched controls
- Conditions
- Atopic Dermatitis
- Being tested
- Actigraphy Device
- Keywords
- Scratching
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraphy DeviceDevice
Patients will wear actigraphy device which detects scratching events.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects Receives: Device: Actigraphy Device | |
| Atopic dermatitis | Atopic dermatitis Receives: Device: Actigraphy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and precision of the scratching algorithm with reference to the gold standard.
Assessment of the performance of the scratching algorithm as detected by actigraphy compared to infra red video monitoring.
Measured: Through study completion, analyst review following each patient's overnight intervention/session
Secondary outcomes (1)
Agreement via additional performance metrics between the scratching algorithm and the gold standard.
Overall agreement of algorithm-determined scratching events and total duration compared to video scoring of scratching events; Other performance metrics such as Cohen's kappa and correlation between the number and duration of scratching events detected by the scratching algorithm versus video scoring
Measured: Through study completion, analyst review following each patient's overnight intervention/session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start10 Dec 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137093
- Sponsor's protocol ID
- SRC_NBS_GENEActiv_2019_10763
- Status last verified
- Mar 2023
- First submitted
- 5 Nov 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Validation Study of Nighttime Scratching Quantification With Actigraphy in Adults With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05137093
- Acronym / sponsor ID
- SRC_NBS_GENEActiv_2019_10763
- Conditions
- Atopic Dermatitis
- Keywords
- Scratching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 30 Nov 2021 (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.
Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls.
Detailed description
The Philips scratching algorithm has been cross-validated against the gold-standard assessment of scratching. The algorithm has been used in many drug development trials, occasionally as a means of generating secondary endpoints, but most often as a means of generating exploratory endpoints. The purpose of the proposed study is therefore to validate the data generated by the scratching study compared to the gold-standard video-assessment of scratching, in an independent sample of adults with atopic dermatitis and age- and sex-matched controls
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: Actigraphy DeviceHealthy subjects |
| Atopic dermatitis | – | Device: Actigraphy DeviceAtopic dermatitis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy \& Atopic dermatitis subjects
Key inclusion criteria (7 listed)
- Be aged 18 to 75 years, inclusive
- Be willing and able to undergo a single night of actigraphy and video monitoring overnight in a laboratory
- Be willing and able to provide informed consent
- (patients only): Diagnosed with atopic dermatitis by a clinician, following the criteria listed in Table 1.
- (patients only): IGA score ≥ 2.
Key exclusion criteria (27 listed)
- Any acute and/or unstable illness or medical complication which, in the opinion of a clinician, could compromise data collection and/or interpretation
- Use of any over-the-counter, prescription, or recreational drugs that may induce sleep or pruritus within 24 hours prior to overnight monitoring
- Use of any over-the-counter or prescription treatment (systemic, or topical) that could affect the course of atopic dermatitis during the study period. Key medications are listed below:
- Individuals clinically diagnosed with a sleep disorder who are NOT on a controlled treatment regime
- An Epworth Sleepiness Scale score of ≥11, indicating daytime hypersomnolence
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 |
|---|---|---|
| Actigraphy DevicePatients will wear actigraphy device which detects scratching events. | Device | Atopic dermatitis, Healthy subjects |
Primary outcome
Sensitivity and precision of the scratching algorithm with reference to the gold standard.
Time frame: Through study completion, analyst review following each patient's overnight intervention/session
Assessment of the performance of the scratching algorithm as detected by actigraphy compared to infra red video monitoring.
1 secondary outcome
Agreement via additional performance metrics between the scratching algorithm and the gold standard.
Time frame: Through study completion, analyst review following each patient's overnight intervention/session
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 9 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
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?
An observational study of Atopic Dermatitis, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
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 7 inclusion and 27 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 9 Mar 2023. 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 United States. 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?
Sensitivity and precision of the scratching algorithm with reference to the gold standard. (time frame: Through study completion, analyst review following each patient's overnight intervention/session). 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 9 Mar 2023.