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Topical Treatment for Atopic Dermatitis

NCT ID: NCT06244212

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2027-07-31

Brief Summary

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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

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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).

Conditions

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Atopic Dermatitis

Keywords

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Medication adherence topical medications Triamcinolone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Demonstration

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

Group Type ACTIVE_COMPARATOR

Demonstration of applying triamcinolone cream

Intervention Type OTHER

Live demonstration of applying 1 fingertip unit of triamcinolone cream

Mobile Application

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

Group Type EXPERIMENTAL

Mobile App Use

Intervention Type BEHAVIORAL

Additional mobile application that provides amount dispensed and adherence data.

Written/verbal instructions only

Standard of care written/verbal instructions only

Group Type OTHER

Standard of Care

Intervention Type OTHER

Written/verbal instructions only

Interventions

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Demonstration of applying triamcinolone cream

Live demonstration of applying 1 fingertip unit of triamcinolone cream

Intervention Type OTHER

Mobile App Use

Additional mobile application that provides amount dispensed and adherence data.

Intervention Type BEHAVIORAL

Standard of Care

Written/verbal instructions only

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Irma Richardson, MHA

Role: CONTACT

Phone: 336.716.2903

Email: [email protected]

Facility Contacts

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Irma Richardson, MHA

Role: primary

Other Identifiers

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IRB00108458

Identifier Type: -

Identifier Source: org_study_id