Scratching Validation Study

NCT ID: NCT05137093

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2023-02-01

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy subjects

Healthy subjects

Actigraphy Device

Intervention Type: DEVICE

Patients will wear actigraphy device which detects scratching events.

Atopic dermatitis

Atopic dermatitis

Actigraphy Device

Intervention Type: DEVICE

Patients will wear actigraphy device which detects scratching events.

Interventions

Actigraphy Device

Patients will wear actigraphy device which detects scratching events.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clayton Sleep Institute

Maplewood, Missouri, United States

Countries

United States

Other Identifiers

SRC_NBS_GENEActiv_2019_10763

Identifier Type: -

Identifier Source: org_study_id