Evaluation of atopic dermatitis in children
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
This study looks at children with moderate to severe eczema who aren't getting better with creams to see how the condition affects them and what treatments work best over ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1845 (estimated) |
| Ages | 0 Years to 11 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 181 sites (Birmingham, Alabama and 180 other locations) |
| Trial ID | NCT03687359 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe the characteristics of pediatric patients suffering from moderate to severe atopic dermatitis (AD) who are not adequately controlled with topical therapies or for whom such therapies are not advisable. It will evaluate the time-course of AD and associated atopic comorbidities, while also characterizing the disease burden and unmet needs of these patients. Additionally, the study will document real-world treatment patterns, effectiveness, and safety of various treatments over a duration of 120 months.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients with moderate to severe atopic dermatitis currently receiving systemic treatment or those on topical treatment who are candidates for systemic therapy.
Not a fit: Patients who are concurrently participating in an interventional clinical trial that modifies their care will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and treatment of pediatric atopic dermatitis, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown success in evaluating atopic dermatitis in pediatric populations, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 180 other locations
- C Squared Research Center- Site Number : 8400068 — Birmingham, Alabama, United States (Recruiting)
- Cahaba Dermatology & Skin Health Center- Site Number : 8400046 — Birmingham, Alabama, United States (Recruiting)
- C2 Research Center, LLC- Site Number : 8400071 — Montgomery, Alabama, United States (Recruiting)
- Phoenix Children's Hospital, Inc.- Site Number : 8400015 — Phoenix, Arizona, United States (Recruiting)
- Orange County Research Institute- Site Number : 8400028 — Anaheim, California, United States (Recruiting)
- Axis Clinical Trials- Site Number : 8400025 — Los Angeles, California, United States (Recruiting)
- Madera Family Medical Group- Site Number : 8400054 — Madera, California, United States (Recruiting)
- Carey Chronis, MD, FAAP- Site Number : 8400033 — Ventura, California, United States (Recruiting)
- Daxia Trials- Site Number : 8400082 — Boca Raton, Florida, United States (Recruiting)
- Frieder Dermatology- Site Number : 8400085 — Boca Raton, Florida, United States (Recruiting)
- Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400072 — Coral Gables, Florida, United States (Recruiting)
- Green Dermatology and Cosmetic Center. Site Number : 8400078 — Deerfield Beach, Florida, United States (Recruiting)
- Amedica Research Institute, Inc.- Site Number : 8400067 — Hialeah, Florida, United States (Recruiting)
- Eastern Research, Inc.- Site Number : 8400032 — Hialeah, Florida, United States (Active_not_recruiting)
- Premier Dermatology Partners- Site Number : 8400075 — Miami, Florida, United States (Recruiting)
- Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074 — Miami, Florida, United States (Recruiting)
- Ciocca, Giovanna- Site Number : 8400018 — Miami, Florida, United States (Recruiting)
- Vista Health Research, LLC- Site Number : 8400034 — Miami, Florida, United States (Recruiting)
- Pediatric & Adult Research Center- Site Number : 8400040 — Orlando, Florida, United States (Recruiting)
- Elias Dermatology LLC- Site Number : 8400086 — Pembroke Pines, Florida, United States (Recruiting)
- Elias Dermatology LLC- Site Number : 8400087 — Pembroke Pines, Florida, United States (Recruiting)
- Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056 — Columbus, Georgia, United States (Recruiting)
- Northwestern University Feinberg School of Medicine- Site Number : 8400001 — Chicago, Illinois, United States (Recruiting)
- NorthShore University HealthSystem - Skokie- Site Number : 8400064 — Skokie, Illinois, United States (Recruiting)
- The Indiana Clinical Trial Center- Site Number : 8400007 — Plainfield, Indiana, United States (Recruiting)
- The Indiana Clinical Trials Center, PC Site Number : 8400007 — Plainfield, Indiana, United States (Recruiting)
- Michael W. Simon, M.D., PSC- Site Number : 8400073 — Lexington, Kentucky, United States (Recruiting)
- Dermatology Associates PC- Site Number : 8400049 — Rockville, Maryland, United States (Recruiting)
- Michigan Dermatology Institute Site Number : 8400059 — Waterford, Michigan, United States (Recruiting)
- Tokunbo T. Dada, MD PA- Site Number : 8400079 — Irvington, New Jersey, United States (Recruiting)
- Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077 — Newark, New Jersey, United States (Recruiting)
- Providence Medical Center- Site Number : 8400081 — North Plainfield, New Jersey, United States (Recruiting)
- VAMA Medical Health Center- Site Number : 8400083 — Union, New Jersey, United States (Recruiting)
- Philip Fried, M.D., PLLC- Site Number : 8400029 — Bronx, New York, United States (Recruiting)
- Tiga Pediatrics, PC- Site Number : 8400037 — Bronx, New York, United States (Recruiting)
- Park Plaza Dermatology- Site Number : 8400080 — New York, New York, United States (Recruiting)
- UNC Hospitals- Site Number : 8400016 — Chapel Hill, North Carolina, United States (Recruiting)
- 2G Clinical Research Services- Site Number : 8400031 — Durham, North Carolina, United States (Recruiting)
- Clinical Research Of Gastonia- Site Number : 8400041 — Gastonia, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center- Site Number : 8400017 — Cincinnati, Ohio, United States (Recruiting)
- Dermatology Associates of Mid-Ohio- Site Number : 8400052 — Marion, Ohio, United States (Recruiting)
- MUSC- Site Number : 8400013 — Charleston, South Carolina, United States (Recruiting)
- ADAC Research- Site Number : 8400048 — Greenville, South Carolina, United States (Recruiting)
- Amarillo Center for Clinical Research- Site Number : 8400055 — Amarillo, Texas, United States (Recruiting)
- ACRC Trials - Pediatric Dermatology of North Texas- Site Number : 8400003 — Grapevine, Texas, United States (Recruiting)
- Heights Dermatology & Aesthetic Center- Site Number : 8400065 — Houston, Texas, United States (Recruiting)
- The Dermatology Institute of South Texas- Site Number : 8400076 — McAllen, Texas, United States (Recruiting)
- Medical College Of Wisconsin- Site Number : 8400008 — Milwaukee, Wisconsin, United States (Recruiting)
- Investigational Site Number : 0320009 — Bahía Blanca, Buenos Aires, Argentina (Recruiting)
- Investigational Site Number : 0320003 — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (Recruiting)
+131 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.