scratching validation study

Conditions: Atopic Dermatitis

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.

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

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.

Keywords: scratching