Topical Treatment for Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Topical Treatment for Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244212
• Other study ID #: IRB00108458
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Irma Richardson, MHA
• Phone: 336.716.2903
• Email: irichard[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Demonstration of applying triamcinolone cream
Live demonstration of applying 1 fingertip unit of triamcinolone cream

Behavioral:
• Mobile App Use
Additional mobile application that provides amount dispensed and adherence data.

Other:
• Standard of Care
Written/verbal instructions only

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Topical Medication Dispensed - Demonstration Group	Amount of Topical Medication Dispensed in grams	Day 7
Primary	Amount of Topical Medication Dispensed - Standard of Care Group	Amount of Topical Medication Dispensed in grams	Day 7
Primary	Amount of Topical Medication Dispensed - Mobile Application Group	Amount of Topical Medication Dispensed in grams	Day 7
Primary	Number of times of Application - Demonstration Group	Frequency of Application	Day 7
Primary	Number of times of Application - Standard of Care Group	Frequency of Application	Day 7
Primary	Number of times of Application - Mobile Application Group	Frequency of Application	Day 7
Primary	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
Primary	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
Primary	Subject Questionnaire Scores	a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.	Day 7