Atopic DermatitisNCT06244212
Topical Treatment for Atopic Dermatitis
A study testing Demonstration of applying triamcinolone cream and Mobile App Use in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Demonstration of applying triamcinolone cream and Mobile App Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients without the diagnosis of skin dermatitis
- Inability to return for a one week follow up appointment
- Body Surface Area (BSA) affected <2%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Irma Richardson, MHA, 336-716-2903, irichard@wakehealth.edu
Steven R Feldman, MD, PhD
About this study
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).
- Conditions
- Atopic Dermatitis
- Being tested
- Demonstration of applying triamcinolone cream, Mobile App Use, Standard of Care
- Keywords
- Medication adherence, topical medications, Triamcinolone
- Medical subject headings
- Dermatitis, Atopic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demonstration of applying triamcinolone creamOther
Live demonstration of applying 1 fingertip unit of triamcinolone cream
Mobile App UseBehavioural
Additional mobile application that provides amount dispensed and adherence data.
Standard of CareOther
Written/verbal instructions only
| Study group | Role | What they receive |
|---|---|---|
| Demonstration | Active comparator | Observe a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area Receives: Other: Demonstration of applying triamcinolone cream |
| Mobile Application | Experimental | Additional mobile application that provides instructions to apply the medication (triamcinolone cream) Receives: Behavioral: Mobile App Use |
| Written/verbal instructions only | Other | Standard of care written/verbal instructions only Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Topical Medication Dispensed - Demonstration Group
Amount of Topical Medication Dispensed in grams
Measured: Day 7
Amount of Topical Medication Dispensed - Standard of Care Group
Amount of Topical Medication Dispensed in grams
Measured: Day 7
Amount of Topical Medication Dispensed - Mobile Application Group
Amount of Topical Medication Dispensed in grams
Measured: Day 7
Number of times of Application - Demonstration Group
Frequency of Application
Measured: Day 7
Number of times of Application - Standard of Care Group
Frequency of Application
Measured: Day 7
Number of times of Application - Mobile Application Group
Frequency of Application
Measured: 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.
Measured: 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)
Measured: Baseline and Day 7
Subject Questionnaire Scores
a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start19 Sep 2024
- Primary completionJan 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244212
- Sponsor's protocol ID
- IRB00108458
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Treatment for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06244212
- Acronym / sponsor ID
- IRB00108458
- Conditions
- Atopic Dermatitis
- Keywords
- Medication adherence, topical medications, Triamcinolone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.
| Arm | Type | Receives |
|---|---|---|
| Demonstration | Active comparator | Other: Demonstration of applying triamcinolone creamObserve a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area |
| Mobile Application | Experimental | Behavioral: Mobile App UseAdditional mobile application that provides instructions to apply the medication (triamcinolone cream) |
| Written/verbal instructions only | Other | Other: Standard of CareStandard of care written/verbal instructions only |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients without the diagnosis of skin dermatitis
- Inability to return for a one week follow up appointment
- Body Surface Area (BSA) affected <2%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demonstration of applying triamcinolone creamLive demonstration of applying 1 fingertip unit of triamcinolone cream | Other | Demonstration |
| Mobile App UseAdditional mobile application that provides amount dispensed and adherence data. | Behavioural | Mobile Application |
| Standard of CareWritten/verbal instructions only | Other | Written/verbal instructions only |
Primary outcome
Amount of Topical Medication Dispensed - Demonstration Group
Time frame: Day 7
Amount of Topical Medication Dispensed in grams
Amount of Topical Medication Dispensed - Standard of Care Group
Time frame: Day 7
Amount of Topical Medication Dispensed in grams
Amount of Topical Medication Dispensed - Mobile Application Group
Time frame: Day 7
Amount of Topical Medication Dispensed in grams
Number of times of Application - Demonstration Group
Time frame: Day 7
Frequency of Application
Number of times of Application - Standard of Care Group
Time frame: Day 7
Frequency of Application
Number of times of Application - Mobile Application Group
Time frame: Day 7
Frequency of Application
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.
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)
Subject Questionnaire Scores
Time frame: Day 7
a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demonstration of applying triamcinolone cream and Mobile App Use in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma Richardson, MHA (336.716.2903, irichard@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Topical Medication Dispensed - Demonstration Group (time frame: Day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.