CClinicalTrials.gg
Sign In
CompletedNCT01675232Updated Jul 29, 2014

A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis

An interventional study of Soak and smear and Dry Smear in Atopic Dermatitis, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 2 Weeks to 18 Years. Per ClinicalTrials.gov, last updated 2014-07-29.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
2 Weeks to 18 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic dermatitis
  • Topical corticosteroid
  • Pediatric
  • Eczema
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 45 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Weeks to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meet the clinical criteria for the diagnosis of atopic dermatitis
  • Have disease over at least 5% of their total body surface area.
  • Less than 18 years of age.
  • Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
  • Parents/guardians able to understand and willing to sign a parental permission form.
  • Children between the ages of 7-17 years willing to sign an age-appropriate assent form.

Exclusion criteria

Exclusion Criteria:

  • Patients who are allergic or intolerant of the topical medications employed in this study.
  • Lack of follow-up after initial visit or regimen noncompliance.
  • Patients who do not have access to a bathtub.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Soak and smear

    Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day.

    Other: Soak and smear

  • Active comparator
    Dry smear

    Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.

    Other: Dry Smear

Interventions

  • OtherSoak and smear

    Corticosteroid ointment applied to wet skin once a day and dry skin once a day.

  • OtherDry Smear

    Corticosteroid ointment applied to dry skin twice a day.

06

What researchers measure

Primary outcomes

  1. Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)

    Time frame: 2 weeks

Secondary outcomes

  1. Effect of corticosteroid ointment application regimens on serum cortisol

    Time frame: 2 weeks after application of topical corticosteroids

  2. Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen

    Time frame: 3 months

  3. Adverse effects associated with each corticosteroid application regimen

    Characterize and quantify adverse effects associated with each corticosteroid application regimen.

    Time frame: 3 months

07

Study locations

1 site
  • Yale University
    New Haven, Connecticut 06510, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01675232
Lead sponsor
Yale University
Responsible party
Richard Antaya (Professor of Dermatology and Pediatrics, Yale University) — Principal investigator
First posted
Aug 29, 2012
Start date
Jul 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 29, 2014

Study contacts

Richard J Antaya, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatitis, Atopic→

Other studies from this sponsor

Yale University

Start the discussion