Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
During the first hospital visit demographic data, information about the disease course in recent years and medication use will be collected. Also, patient-reported outcomes questionnaires will be comp
Sponsors
Pfizer (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =12 years of age (12-15 and =16 years of age) 2. Clinical diagnosis of atopic dermatitis (AD) 3. Severity of AD classified as moderate to severe as per the selected Investigator Global Assessment (IGA) scale (Validated Investigator’s Global Assessment (vIGA-AD): vIGA-AD =3). Grade 3 is defined as clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present. [Simpson 2020] 4. Evidence of a personally signed and dated informed consent (assent) document indicating that the patient (or a legally acceptable representative) has been informed of and consented (assented where applicable) to all pertinent aspects of the study. Parents (or a legally acceptable representative) will sign the consent form for patients <18 years of age 5. Seeking medical attention for AD to the clinic for the first time (no previous visit for AD), including: 5.1. New M2S AD patients who present themselves for the first time at the center of reference 5.2. Known M2S AD patients who haven’t been in regular follow-up for at least 2 years 5.3. Patient referred within the center who fulfils the above criteria
Exclusion criteria
Exclusion criteria: 1. Current participation in interventional clinical study 2. Other active concurrent dermatological conditions which may confound correct diagnosis or symptom scores (i.e., psoriasis, chronic urticaria) 3. Children <12 years of age or mild severity of AD as per vIGA-AD (vIGA-AD equal or less than 2, where 2 is mild erythema, and mild papulation/infiltration)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All measurements (completion of questionnaires) will be done once only during the first hospital visit: 1. How much skin pain has affected the patient’s life over the last week, measured using the Dermatology Life Quality Index (DLQI) 2. For patients under 16 years of age: How much skin pain has affected the patient’s life over the last week, measured using the Children Dermatology Life Quality Index (CDLQI)] 3. Health-related quality of life; mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured using EuroQol-5 Dimensions-3 Level scale (EQ-5D-3L) 4, How much having a child with atopic dermatitis affects the quality of life of other (adult) members of the family, measured using the Dermatitis Family Impact (DFI) 5. Symptoms/itch and impact on the domains of work, and sleep disturbance and pain, measured using the Patient Oriented Eczema Measure (POEM), Peak Prutitus Numerical Severity Scale (PP-NRS), Work Productivity and Activity Impairment Questionnaire (WPAI) 6. Sleep disturbance and pain measured using self-reported sleep and pain measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| During the first visit the following information of the patient will be collected once only from the patient’s medical records (no measurements or interventions are needed): 1. Main characteristics of this patient population (sociodemographic, clinical, including body surface area [BSA], specific areas of interest involved, etc) using descriptive statistics and severity expressed as a percentage of patients with AD of different severity in the selected cohort 2. Drug categories used currently and in the past, in this patient population 3. Main characteristics of healthcare resources utilized, including specialty and frequency of consultation of involved healthcare professionals (HCPs), hospital visits or hospitalizations for AD in last year (unless defined otherwise) using descriptive statistics | — |
Countries
Netherlands
Outcome results
None listed