A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists

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.

Inclusion Criteria:

1. Meet the clinical criteria for the diagnosis of atopic dermatitis

2. Have disease over at least 5% of their total body surface area.

3. Less than 7 years of age.

4. Families able to comprehend written instructions in English and able to complete
questionnaires with assistance if needed.

5. Parents/guardians able to understand and willing to sign a parental permission form.

Exclusion Criteria:

1. Clinically infected atopic dermatitis.

2. Lack of follow-up after initial visit or regimen non-adherence.

3. Patients who are allergic or intolerant of the topical medications employed in this
study.