APOLO: AtoPic dermatitis - a crOss sectionaL study on disease characteristics and impact On patients

Pfizer (Netherlands)0 sites150 target enrollmentOctober 11, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 11, 2021

End Date

August 1, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Sponsor

Pfizer (Netherlands)

•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

•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)