Research into the disease burden in patients with atopic eczema

Not Applicable

• Conditions: Atopic dermatitis; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN84958399
• Lead Sponsor: Pfizer (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-11
• Study Completion: 2022-08-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 150

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified