Topical Treatment for Atopic Dermatitis

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT06244212
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Study Start: 2024-09-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of Topical Medication Dispensed - Standard of Care Group	Day 7	Amount of Topical Medication Dispensed in grams
Amount of Topical Medication Dispensed - Demonstration Group	Day 7	Amount of Topical Medication Dispensed in grams
Amount of Topical Medication Dispensed - Mobile Application Group	Day 7	Amount of Topical Medication Dispensed in grams
Number of times of Application - Demonstration Group	Day 7	Frequency of Application
Change in Investigator Global Assessment (IGA) Scores	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.
Number of times of Application - Standard of Care Group	Day 7	Frequency of Application
Number of times of Application - Mobile Application Group	Day 7	Frequency of Application
Subject Questionnaire Scores	Day 7	a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.
Change in Percentage of Body Surface Area (BSA) affected	Baseline and Day 7	Body Surface Area percentage = 0.007184 x (Height(cm)\^0.725) x (Weight(kg)\^0.425)

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States