Topical Treatment for Atopic Dermatitis

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: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Demonstration of applying triamcinolone cream; Behavioral: Mobile App Use; Other: Standard of Care

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

• Study Contact: Name: Irma Richardson, MHA; Phone Number: 336.716.2903; Email: irichard@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Irma Richardson, MHA; Phone Number: 336-716-2903; Email: irichard@wakehealth.edu
      • Principal Investigator: Steven R Feldman, MD, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Medication adherence; Triamcinolone; topical medications
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• 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