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RecruitingNCT06244212Updated Aug 4, 2026

Topical Treatment for Atopic Dermatitis

An interventional study of Demonstration of applying triamcinolone cream and Mobile App Use in Atopic Dermatitis, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study 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.

Read the detailed 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).

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Medication adherence
  • topical medications
  • Triamcinolone
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 30 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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%
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Demonstration

    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

  • Experimental
    Mobile Application

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

    Behavioral: Mobile App Use

  • Other
    Written/verbal instructions only

    Standard of care written/verbal instructions only

    Other: Standard of Care

Interventions

  • OtherDemonstration of applying triamcinolone cream

    Live demonstration of applying 1 fingertip unit of triamcinolone cream

  • BehavioralMobile App Use

    Additional mobile application that provides amount dispensed and adherence data.

  • OtherStandard of Care

    Written/verbal instructions only

06

What researchers measure

Primary outcomes

  1. Amount of Topical Medication Dispensed - Demonstration Group

    Amount of Topical Medication Dispensed in grams

    Time frame: Day 7

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

    Amount of Topical Medication Dispensed in grams

    Time frame: Day 7

  3. Amount of Topical Medication Dispensed - Mobile Application Group

    Amount of Topical Medication Dispensed in grams

    Time frame: Day 7

  4. Number of times of Application - Demonstration Group

    Frequency of Application

    Time frame: Day 7

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

    Frequency of Application

    Time frame: Day 7

  6. Number of times of Application - Mobile Application Group

    Frequency of Application

    Time frame: Day 7

  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.

    Time frame: Baseline and Day 7

  8. 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)

    Time frame: Baseline and Day 7

  9. Subject Questionnaire Scores

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

    Time frame: Day 7

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06244212
Responsible party
Sponsor
First posted
Feb 6, 2024
Start date
Sep 19, 2024
Primary completion
Jan 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 4, 2026

Study contacts

Irma Richardson, MHA
Contact
irichard@wakehealth.edu
336.716.2903
Steven R Feldman, MD, PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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