Topical Treatment for Atopic Dermatitis

Wake Forest University (WFU)

Status: Enrolling

Conditions: Atopic Dermatitis

Treatments: Other: Standard of Care; Other: Demonstration of applying triamcinolone cream; Behavioral: Mobile App Use

Study type: Interventional

Funder types: Other

Identifiers

NCT06244212

IRB00108458

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Demonstration

Active Comparator group

Description:

Observe a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area

Treatment:

Other: Demonstration of applying triamcinolone cream

Mobile Application

Experimental group

Description:

Additional mobile application that provides instructions to apply the medication (triamcinolone cream)

Treatment:

Behavioral: Mobile App Use

Written/verbal instructions only

Other group

Description:

Standard of care written/verbal instructions only

Treatment:

Other: Standard of Care