Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03687359

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

Primary Objectives:

* To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. * To evaluate the time-course of AD and selected atopic comorbidities.

Secondary Objectives:

* To characterize disease burden and unmet need. * To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). * To document the real-world effectiveness and safety of treatments.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

0 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 0320009, Bahía Blanca, Buenos Aires, Argentina

Loading trial locations.

About this study

The study duration is 120 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe AD, according to the Investigator's assessment;
  • Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.

Exclusion criteria

  • Concurrent participation in an interventional clinical trial which modifies patient care.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Standard of care

Other

Treatment as per standard practice

Primary outcomes

  1. Patient demographics

    Time frame: Baseline (Month 0)

  2. Medical history of selected atopic diseases and comorbidities

    Time frame: Baseline (Month 0)

  3. Age at onset of atopic dermatitis (AD)

    Time frame: Baseline (Month 0)

  4. Personal and family history of AD and selected atopic diseases

    Time frame: Baseline (Month 0)

  5. All prior and current systemic AD treatment

    Time frame: Baseline (Month 0)

  6. All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)

    Time frame: Baseline (Month 0)

  7. Presence/severity of AD and selected atopic comorbid conditions

    Time frame: Baseline to Month 120

  8. Therapy for selected atopic comorbid conditions

    Time frame: Baseline to Month 120

Secondary outcomes

  1. Days missed from school for the patient and days missed from work for the primary caregiver due to AD

    Time frame: Baseline to Month 120

  2. Visits to healthcare professionals (HCPs)

    Time frame: Baseline to Month 120

  3. Treatments and prescribing patterns for pediatric AD

    Time frame: Baseline to Month 120

  4. Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])

    Time frame: Baseline to Month 120

  5. Changes in physician assessment of disease burden (Body Surface Area [BSA])

    Time frame: Baseline to Month 120

  6. Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)

    Time frame: Baseline to Month 120

  7. Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)

    Time frame: Baseline to Month 120

  8. Change in PRO: Dermatitis Family Impact (DFI)

    Time frame: Baseline to Month 120

  9. Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS

    Time frame: Baseline to Month 120

  10. Change in PRO: Caregiver Global Assessment of Disease (CGAD)

    Time frame: Baseline to Month 120

  11. Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit

    Time frame: Baseline to Month 120

  12. Change in PRO: Total Nasal Symptom Score (TNSS)

    Time frame: Baseline to Month 120

  13. Change in PRO: Pediatric Asthma Questionnaire (PAQ)

    Time frame: Baseline to Month 120

  14. Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)

    Time frame: Baseline to Month 120

  15. Adverse event (AE) reporting

    Time frame: Baseline to Month 120

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Acronym: PEDISTAD

Important dates

Study start
2019
Primary completion
2035
Study completion
2035
First posted
Sep 27, 2018
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.