Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02916888
Study type Observational
Source Yale University
Contact
Status Completed
Phase N/A
Start date September 2016
Completion date December 2017

See also
  Status Clinical Trial Phase
Completed NCT03563066 - Effect of Benralizumab in Atopic Dermatitis Phase 2
Terminated NCT04086121 - A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032 Phase 2
Recruiting NCT04011215 - Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2) N/A
Completed NCT04635072 - Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis Early Phase 1
Completed NCT01945086 - A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis Phase 2
Completed NCT00541255 - A Long-Term Examination of Asthma From Childhood Through Adolescence
Terminated NCT04990440 - A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT02900131 - Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients Phase 2
Completed NCT03568136 - Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis Phase 2
Recruiting NCT01631617 - Effects of Treatments on Atopic Dermatitis Phase 2
Completed NCT03672383 - Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation) N/A
Completed NCT03634345 - Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842. Phase 1
Enrolling by invitation NCT04761978 - Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
Completed NCT03663673 - Effect of Different Skin Creams on TEWL Phase 1
Recruiting NCT05177744 - Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
Completed NCT03720470 - Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy Phase 3
Completed NCT02637206 - Skin Irritation Study of GSK2894512 Cream Phase 1
Completed NCT05544591 - Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT05094700 - A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants N/A
Terminated NCT02582788 - Bathing Additives in Pediatric Atopic Dermatitis N/A