ACTIVE_NOT_RECRUITING

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2019-08-15
Study Completion:2035-07-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03687359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients with moderate to severe AD, according to the Investigator's assessment;
  2. * Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.
  1. * Concurrent participation in an interventional clinical trial which modifies patient care.

Contacts and Locations

Principal Investigator

Clinical Sciences & Operations
STUDY_DIRECTOR
Sanofi

Study Locations (Sites)

C Squared Research Center- Site Number : 8400068
Birmingham, Alabama, 35209
United States
Cahaba Dermatology & Skin Health Center- Site Number : 8400046
Birmingham, Alabama, 35244
United States
C2 Research Center, LLC- Site Number : 8400071
Montgomery, Alabama, 36117
United States
Phoenix Children's Hospital, Inc.- Site Number : 8400015
Phoenix, Arizona, 85016
United States
Orange County Research Institute- Site Number : 8400028
Anaheim, California, 92801
United States
Axis Clinical Trials- Site Number : 8400025
Los Angeles, California, 90036
United States
Madera Family Medical Group- Site Number : 8400054
Madera, California, 93637
United States
Carey Chronis, MD, FAAP- Site Number : 8400033
Ventura, California, 93003
United States
Daxia Trials- Site Number : 8400082
Boca Raton, Florida, 33431
United States
Frieder Dermatology- Site Number : 8400085
Boca Raton, Florida, 33487
United States
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072
Coral Gables, Florida, 33146
United States
Green Dermatology and Cosmetic Center. Site Number : 8400078
Deerfield Beach, Florida, 33441
United States
Amedica Research Institute, Inc.- Site Number : 8400067
Hialeah, Florida, 33013
United States
Eastern Research, Inc.- Site Number : 8400032
Hialeah, Florida, 33013
United States
Premier Dermatology Partners- Site Number : 8400075
Miami, Florida, 33137
United States
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074
Miami, Florida, 33155
United States
Vista Health Research, LLC- Site Number : 8400034
Miami, Florida, 33176
United States
Pediatric & Adult Research Center- Site Number : 8400040
Orlando, Florida, 32825
United States
Elias Dermatology LLC- Site Number : 8400086
Pembroke Pines, Florida, 33024
United States
Elias Dermatology LLC- Site Number : 8400087
Pembroke Pines, Florida, 33024
United States
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056
Columbus, Georgia, 31904
United States
Northwestern University Feinberg School of Medicine- Site Number : 8400001
Chicago, Illinois, 60611
United States
NorthShore University HealthSystem - Skokie- Site Number : 8400064
Skokie, Illinois, 60077
United States
The Indiana Clinical Trial Center - Plainfield - Edwards Drive- Site Number : 8400007
Plainfield, Indiana, 46168
United States
The Indiana Clinical Trials Center, PC Site Number : 8400007
Plainfield, Indiana, 46168
United States
Michael W. Simon, M.D., PSC- Site Number : 8400073
Lexington, Kentucky, 40517
United States
Dermatology Associates PC- Site Number : 8400049
Rockville, Maryland, 20850
United States
Michigan Dermatology Institute Site Number : 8400059
Waterford, Michigan, 48328
United States
Tokunbo T. Dada, MD PA- Site Number : 8400079
Irvington, New Jersey, 07111
United States
Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077
Newark, New Jersey, 07104
United States
Providence Medical Center- Site Number : 8400081
North Plainfield, New Jersey, 07060
United States
VAMA Medical Health Center- Site Number : 8400083
Union, New Jersey, 07083-5714
United States
Philip Fried, M.D., PLLC- Site Number : 8400029
Bronx, New York, 10463
United States
Tiga Pediatrics, PC- Site Number : 8400037
Bronx, New York, 10463
United States
Park Plaza Dermatology- Site Number : 8400080
New York, New York, 10019
United States
UNC Hospitals- Site Number : 8400016
Chapel Hill, North Carolina, 27514
United States
2G Clinical Research Services- Site Number : 8400031
Durham, North Carolina, 27713
United States
Clinical Research Of Gastonia- Site Number : 8400041
Gastonia, North Carolina, 28054
United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400017
Cincinnati, Ohio, 45229
United States
Dermatology Associates of Mid-Ohio- Site Number : 8400052
Marion, Ohio, 43302
United States
MUSC- Site Number : 8400013
Charleston, South Carolina, 29425
United States
ADAC Research- Site Number : 8400048
Greenville, South Carolina, 29607
United States
Amarillo Center for Clinical Research- Site Number : 8400055
Amarillo, Texas, 79124
United States
Heights Dermatology & Aesthetic Center- Site Number : 8400065
Houston, Texas, 77008
United States
The Dermatology Institute of South Texas- Site Number : 8400076
McAllen, Texas, 78501
United States
Medical College Of Wisconsin- Site Number : 8400008
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Sanofi

  • Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-15
Study Completion Date2035-07-23

Study Record Updates

Study Start Date2019-08-15
Study Completion Date2035-07-23

Terms related to this study

Additional Relevant MeSH Terms

  • Dermatitis Atopic