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NCT Number: NCT06244212

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.

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Key information

Conditions

Atopic Dermatitis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Irma Richardson, MHA

CONTACT

[email protected]

336-716-2903

Steven R Feldman, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Demonstration of applying triamcinolone cream

Other

Live demonstration of applying 1 fingertip unit of triamcinolone cream

Mobile App Use

Behavioral

Additional mobile application that provides amount dispensed and adherence data.

Standard of care

Other

Written/verbal instructions only

Primary outcomes

  1. Amount of Topical Medication Dispensed - Demonstration Group

    Time frame: Day 7

    Amount of Topical Medication Dispensed in grams

  2. Amount of Topical Medication Dispensed - Standard of Care Group

    Time frame: Day 7

    Amount of Topical Medication Dispensed in grams

  3. Amount of Topical Medication Dispensed - Mobile Application Group

    Time frame: Day 7

    Amount of Topical Medication Dispensed in grams

  4. Number of times of Application - Demonstration Group

    Time frame: Day 7

    Frequency of Application

  5. Number of times of Application - Standard of Care Group

    Time frame: Day 7

    Frequency of Application

  6. Number of times of Application - Mobile Application Group

    Time frame: Day 7

    Frequency of Application

  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.

  8. 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)

  9. Subject Questionnaire Scores

    Time frame: Day 7

    a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.

Study contacts

Contact information is provided by the study sponsor or research team.

Irma Richardson, MHA

CONTACT

[email protected]

336.716.2903

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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