Topical Treatment for Atopic Dermatitis

August 3, 2026 updated by: Wake Forest University Health Sciences
Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Unlike most modes of medication administration, topical medications do not have a standardized method of dosage administration] Although qualitative administration measures exist, these measures are often arbitrary and not quantifiable (i.e., "a fingertip"). In such cases, inappropriate dosing (i.e., using too much or too little) is an essential cause of treatment failure, and measurements of adherence for topical medications should consider the amount of medication administered. In a study analyzing the response to treatment in psoriatic patients, patients who received a standardized dose of topical calcipotriol achieved a more significant decrease in mean Psoriasis Area and Severity Index (PASI) (47%) compared to patients who were not standardized (17%, P<0.0001). Moreover, over two-thirds of psoriatic patients deemed initially poor responders in the standardized regimen group were considered responsive to treatment after further consideration.

Given topical options' low cost, efficacy, and excellent safety profiles, they are the first line treatment option for mild-to-moderate Atopic Dermatitis (AD) treatment. This study will aim to assess differences in the amount of medication dispensed in two groups of patients with atopic dermatitis. The first will undergo a brief educational demonstration by a trained professional to highlight the appropriate amount of topical medication to dispense for their disease involvement. The second group will be a control group and receive the same medication; however, the Participants will receive standard of care education (verbal and written instructions) only. Data from the two groups will be collected and analyzed to measure trends in dosing (i.e., if the correct dosage quantity and frequency was dispensed).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Steven R Feldman, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of skin dermatitis
  • Age > 9
  • Ability to return for a one-week clinical studies follow-up
  • Patients who are candidates for treatment with 0.1% triamcinolone ointment (even if they weren't in the study)
  • Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.

Exclusion Criteria:

  • Patients without the diagnosis of skin dermatitis
  • Inability to return for a one week follow up appointment
  • Body Surface Area (BSA) affected <2%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Demonstration
Observe a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area
Other: Demonstration of applying triamcinolone cream
Live demonstration of applying 1 fingertip unit of triamcinolone cream
Experimental: Mobile Application
Additional mobile application that provides instructions to apply the medication (triamcinolone cream)
Behavioral: Mobile App Use
Additional mobile application that provides amount dispensed and adherence data.
Other: Written/verbal instructions only
Standard of care written/verbal instructions only
Other: Standard of Care
Written/verbal instructions only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Topical Medication Dispensed - Demonstration Group
Time Frame: Day 7
Amount of Topical Medication Dispensed in grams
Day 7
Amount of Topical Medication Dispensed - Standard of Care Group
Time Frame: Day 7
Amount of Topical Medication Dispensed in grams
Day 7
Amount of Topical Medication Dispensed - Mobile Application Group
Time Frame: Day 7
Amount of Topical Medication Dispensed in grams
Day 7
Number of times of Application - Demonstration Group
Time Frame: Day 7
Frequency of Application
Day 7
Number of times of Application - Standard of Care Group
Time Frame: Day 7
Frequency of Application
Day 7
Number of times of Application - Mobile Application Group
Time Frame: Day 7
Frequency of Application
Day 7
Change in Investigator Global Assessment (IGA) Scores
Time Frame: Baseline and Day 7
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. A decrease in score relates to an improvement in signs and symptoms.
Baseline and Day 7
Change in Percentage of Body Surface Area (BSA) affected
Time Frame: Baseline and Day 7
Body Surface Area percentage = 0.007184 x (Height(cm)^0.725) x (Weight(kg)^0.425)
Baseline and Day 7
Subject Questionnaire Scores
Time Frame: Day 7
a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00108458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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