Scratching Validation Study

NCT05137093 | Completed

• 1 other identifier: SRC_NBS_GENEActiv_2019_10763
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Scratching

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Through study completion, analyst review following each patient's overnight intervention/session

Study Arms (2)

Healthy subjects

Healthy subjects

Device: Actigraphy Device

Atopic dermatitis

Atopic dermatitis

Device: Actigraphy Device

Interventions

Actigraphy Device DEVICE

Patients will wear actigraphy device which detects scratching events.

Atopic dermatitis; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy \& Atopic dermatitis subjects

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Clayton Sleep Institute

Maplewood, Missouri, 63143, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 30, 2021
• Study Start: December 10, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)