An observational study in Eczema, Dermatitis and Dermatitis, Atopic, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by Yale University · Observational
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Among 251 studies in Eczema with a site in United States — 33 open to participants now, 47 under way, 9 of them phase 3. Eczema · United States.
Among the 251 studies in Eczema with a site in United States, this one is the 31st largest by enrollment of the 34 observational ones that give a count, is one of 11 that started in 2016, is one of 34 observational ones, and was the 74th registered.
505 studies on the registry are indexed under Eczema; 89 are open to participants now.
Browse Eczema studies →33 of the 251 studies in Eczema with a site in United States are open now. Recruiting first, the newest first:
Weill Medical College of Cornell University · Sites in United States
Ages 13–17
Arcutis Biotherapeutics, Inc. · Sites in United States
Ages 6+
Pfizer · Sites in United States, Canada, Japan and 1 more country
Ages 12+
Pfizer · Sites in United States, Canada, Japan
Ages 12+
University of California, San Francisco · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 66 Eczema studies recruiting now, 31 (47%) set no upper age limit and 27 (41%) stop at 75 or younger; 34 take children under 18; 22 take healthy volunteers.
This study: Up to 7 Years · all sexes · no healthy volunteers.
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251 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 83 · Phase 3 56 · Phase 4 17
First in 2003; this study’s year is marked. 11 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 26 is below the median of 300 across 81 observational studies indexed under Eczema.
Median enrollment 102 across the 216 interventional studies, 243 across the 34 observational. Of the 182 that completed or were terminated, 111 (61%) have results posted.
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164 of 251 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,772 studies on the registry; 296 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 2 studies filed under Eczema — fewer than ten, so there is no comparison to draw.
14 of the studies in Eczema with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07355075Phase 3Turn TherapeuticsA Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema) | 2027-01-20 |
| NCT06807268Phase 3PfizerA Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema | 2027-05-02 |
| NCT07265479Phase 3Organon and CoA Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis | 2027-08 |
| NCT06928246Daniel KaplanThe Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis | 2026-12-15 |
| NCT06504160National Institute of Allergy and Infectious Diseases (NIAID)Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2) | 2026-12-24 |
Add all 14 to your calendar (.ics) → With an account.
Among the 251 studies in Eczema with a site in United States, from their registry updates:
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The purpose of this study is to investigate the differences in the quality of life of patients and caregivers who are treated by general pediatricians versus pediatric dermatologists for eczema (atopic dermatitis or AD).
Hypothesis:
We hypothesize that on average, the patients treated by the general pediatrician will have a smaller increase in quality of life at the end of the 2-week treatment period when compared to patients treated by the specialist.
Methods:
The primary endpoint will be the difference in patient and caregiver quality of life from baseline for the group treated by the general pediatrician and the group treated by the pediatric dermatologist. Secondary endpoints will be the difference in atopic dermatitis severity and TCS phobia from baseline.
Patients will be recruited from the Yale Pediatric Dermatology Clinic and Long Wharf Pediatrics and Adolescent Medicine in New Haven, CT.
Data Collection:
Assessment of AD by the investigator (EASI) and the patient/caregiver (POEM) will be completed at baseline on Day 0 in the clinic. Quality life measures (CDLQI/IDQoL/DFI) and steroid phobia measure (TOPICOP) will also be completed on Day 0. Follow-up clinical assessment will include skin examinations, and will be performed on Day 14. On the follow-up visit, the investigator will perform an assessment of AD severity using the EASI scoring method, ask patients/caregivers to re-take the CDLQI or IDQoL, DFI, POEM and TOPICOP, ask patients/caregivers to report adverse effects, and take digital photography utilizing the same standard poses as baseline. Patients' medication will be weighed to estimate amount of medication used in the 2-week treatment period. We will also instruct the patients and families to treat any subsequent AD flares in a similar manner as the first two weeks of the study, however they will treat until clear and may discontinue prior to 2 weeks of therapy.
Blinding:
This will be a single-blinded study. Patients will only know that there are 2 patient groups that are being treated by physicians, and that these 2 groups are being compared, but will not know that one group is being treated by a generalist and the other by a specialist. Given the study design, it will be impossible to blind investigators.
Treatment Administration:
There will be no research treatment/procedures that are not standard of care treatment. Standard of care treatment will be administered on an outpatient basis. All patients treated will receive a one-page handout, which briefly explains AD and educates families on how to prevent further atopic dermatitis outbreaks. All patients will also receive a page explaining how to apply corticosteroid ointment for treatment of AD.
Patients will adhere to twice daily administration of corticosteroid ointment for 2 weeks, and then will be assessed for clearance of AD. Caregivers or patients will document adherence at home daily in a chart that will be provided to them at their initial visit.
Patients under 7 years old that have atopic dermatitis from the Greater New Haven area.
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Exclusion Criteria:
Standard of care management of atopic dermatitis by general pediatrician. This includes an initial visit with a 2-week follow-up.
Other: Care provided by general pediatrician
Standard of care management of atopic dermatitis by pediatric dermatologist. This includes an initial visit with a 2-week follow-up.
Other: Care provided by pediatric dermatologist
Standard of care management of atopic dermatitis by a general pediatrician.
Standard of care management of atopic dermatitis by a pediatric dermatologist.
Change in quality of life of patients
Measured using Infant's Dermatitis Quality of Life Index (IDQoL) or Children's Dermatology Life Quality Index(CDLQI) depending on age
Time frame: 2 weeks
Change in quality of life of patient caregivers
Measured using Dermatitis Family Impact questionnaire (DFI)
Time frame: 2 weeks
Change in clinical severity of atopic dermatitis
Measured using Eczema Area and Severity Index (EASI) or Patient-Oriented Eczema Measure (POEM)
Time frame: 2 weeks
Change in topical corticosteroid phobia in caregivers
Measured using Topical Corticosteroid Phobia scale (TOPICOP)
Time frame: 2 weeks
Plan to share: Undecided
The record gives a start of Sep 2016, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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