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Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)

NCT ID: NCT03849716

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-05

Study Completion Date

2026-09-30

Brief Summary

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Primary Objective:

To explore associations between biomarkers of atopic dermatitis (AD) and:

* Disease state and time course of AD,
* Disease state and evolution of selected atopic comorbid conditions,
* Effectiveness of specific AD treatments.

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Detailed Description

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The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.

Conditions

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Dermatitis Atopic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with atopic dermatitis (AD)

Participants included in observational study OBS15333 (atopic dermatitis pediatric registry) who consent to enter this companion study LPS15496. Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enter either protocol, and neither protocol OBS15333 nor LPS15496 specifies assignment of any drug intervention

Blood sample

Intervention Type OTHER

Blood samples obtained for biomarker analyses

Cheek swab

Intervention Type OTHER

Cheek swab obtained for genetic analysis

Interventions

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Blood sample

Blood samples obtained for biomarker analyses

Intervention Type OTHER

Cheek swab

Cheek swab obtained for genetic analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participation in the OBS15333 pediatric atopic dermatitis (AD) registry.
* Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.

Exclusion Criteria

Not applicable.

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

0 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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C Squared Research Center Site Number : 8400068

Birmingham, Alabama, United States

Site Status

Cahaba Dermatology Site Number : 8400046

Birmingham, Alabama, United States

Site Status

C2 Research Center, LLC Site Number : 8400071

Montgomery, Alabama, United States

Site Status

Axis Clinical Trials Site Number : 8400025

Los Angeles, California, United States

Site Status

Madera Family Medical Group Site Number : 8400054

Madera, California, United States

Site Status

Fomat Medical Research, Inc. Site Number : 8400033

Oxnard, California, United States

Site Status

Amedica Research Institute, Inc. Site Number : 8400067

Hialeah, Florida, United States

Site Status

Eastern Research, Inc. Site Number : 8400032

Hialeah, Florida, United States

Site Status

Vista Health Research, LLC Site Number : 8400034

Miami, Florida, United States

Site Status

Pediatric & Adult Research Center Site Number : 8400040

Orlando, Florida, United States

Site Status

Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057

Albany, Georgia, United States

Site Status

IACT Health Site Number : 8400056

Columbus, Georgia, United States

Site Status

Northwestern University Feinberg School of Medicine Site Number : 8400001

Chicago, Illinois, United States

Site Status

NorthShore University HealthSystem Site Number : 8400064

Skokie, Illinois, United States

Site Status

Philip Fried, M.D., PLLC Site Number : 8400029

The Bronx, New York, United States

Site Status

Tiga Pediatrics, PC Site Number : 8400037

The Bronx, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center Site Number : 8400017

Cincinnati, Ohio, United States

Site Status

Dermatology Associates of Mid-Ohio Site Number : 8400052

Marion, Ohio, United States

Site Status

MUSC Site Number : 8400013

Charleston, South Carolina, United States

Site Status

Allergic Disease and Asthma Research Center, PA Site Number : 8400048

Greenville, South Carolina, United States

Site Status

Amarillo Center for Clinical Research Site Number : 8400055

Amarillo, Texas, United States

Site Status

Heights Dermatology and Aesthetic Center Site Number : 8400065

Houston, Texas, United States

Site Status

Investigational Site Number : 0320002

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320006

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320004

Rosario, Santa Fe Province, Argentina

Site Status

Investigational Site Number : 0320003

Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320001

Ciudad Autonoma Bs As, , Argentina

Site Status

Investigational Site Number : 0360001

Westmead, New South Wales, Australia

Site Status

Investigational Site Number : 0360003

Melbourne, Victoria, Australia

Site Status

Universidade Federal do Paraná Site Number : 0760003

Curitiba, Paraná, Brazil

Site Status

HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004

Curitiba, Paraná, Brazil

Site Status

HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005

Curitiba, Paraná, Brazil

Site Status

Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Sao Paulo Site Number : 0760006

São Paulo, São Paulo, Brazil

Site Status

Clínica de Alergia Martti Antila Site Number : 0760001

Sorocaba, , Brazil

Site Status

Investigational Site Number : 1240007

Calgary, Alberta, Canada

Site Status

Investigational Site Number : 1240005

Winnipeg, Manitoba, Canada

Site Status

Investigational Site Number : 1240008

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1240006

Montreal, Quebec, Canada

Site Status

Investigational Site Number : 1700001

Bogotá, , Colombia

Site Status

Investigational Site Number : 1700004

Bogotá, , Colombia

Site Status

Investigational Site Number : 2500006

Marseille, , France

Site Status

Investigational Site Number : 2500003

Paris, , France

Site Status

Investigational Site Number : 4840003

Monterrey, Nuevo León, Mexico

Site Status

Investigational Site Number : 4840006

México, , Mexico

Site Status

Investigational Site Number : 4840005

Tlalnepantla, , Mexico

Site Status

Investigational Site Number : 5280005

Groningen, , Netherlands

Site Status

Investigational Site Number : 5280003

Utrecht, , Netherlands

Site Status

Countries

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United States Argentina Australia Brazil Canada Colombia France Mexico Netherlands

Other Identifiers

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U1111-1207-8876

Identifier Type: REGISTRY

Identifier Source: secondary_id

LPS15496

Identifier Type: -

Identifier Source: org_study_id

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