Topical Treatment for Atopic Dermatitis

NCT06244212 | Recruiting

• 1 other identifier: IRB00108458
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Medication adherence; topical medications; Triamcinolone

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

Demonstration

ACTIVE COMPARATOR

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

Mobile Application

EXPERIMENTAL

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

Behavioral: Mobile App Use

Written/verbal instructions only

OTHER

Standard of care written/verbal instructions only

Other: Standard of Care

Interventions

Demonstration of applying triamcinolone cream OTHER

Live demonstration of applying 1 fingertip unit of triamcinolone cream

Demonstration

Mobile App Use BEHAVIORAL

Additional mobile application that provides amount dispensed and adherence data.

Mobile Application

Standard of Care OTHER

Written/verbal instructions only

Written/verbal instructions only

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients without the diagnosis of skin dermatitis
• Inability to return for a one week follow up appointment
• Body Surface Area (BSA) affected \<2%

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma Richardson, MHA

CONTACT

336.716.2903; irichard@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)