Mild to Moderate Atopic DermatitisPhase 1NCT03250663
Eucrisa for Atopic Dermatitis
A Phase 1 study testing Online Treatment response and EUCRISA in people with Mild to Moderate Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Read more about this study
- Who is it for?
- Ages 2 to 64 years
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- Online Treatment response and EUCRISA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 27 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects age 2-64.
- Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.
Who cannot join
- Known allergy to crisaborole or to any component of the formulations.
- The use of systemic therapy for atopic dermatitis within the past 4 weeks.
- Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
- Use of any investigational therapy within the past 4 weeks.
- Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at 6 month and 12 month.
- Any other condition, which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Heath Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Eucrisa for Atopic Dermatitis: Measuring and Improving Adherence to Topical Eucrisa in Patients With Atopic Dermatitis
Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software.
Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter.
Read more
The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD.
Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session).
At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.
Read the detailed description
Atopic Dermatitis (AD) affects between 10% and 30% of all children, making it one of the most common childhood diseases. Recent epidemiological studies report a trend toward the increasing prevalence of AD in children. Symptoms of AD include dry, scaly, and intensely itchy skin. A number of treatments are available for these patients. Topical corticosteroids are commonly prescribed. Topical immunomodulators without the potential for steroid atrophy are also used. A non-steroidal topical, Eucrisa (crisaborole) ointment, is specifically indicated for mild to moderate atopic dermatitis and was approved for marketing in the U.S. for the treatment atopic dermatitis in December 2016. The 2% ointment is approved for use in patients ages 2 and older. Unfortunately, many people with atopic dermatitis do not adequately respond to topical treatment.
It is widely recognized that adherence to oral medications is poor. Adherence to medication in chronic disease is worse. Adherence to topical medication for chronic disease in children is horrible. In a previous study, the investigator found that the adherence of children to topical triamcinolone for atopic dermatitis was poor. Adherence dropped by roughly 60-70% over the first 3 days of treatment. While that study analyzed adherence over 8 weeks, the long-term adherence to topical treatment in patients with atopic dermatitis is not well characterized.
Measures to improve adherence have the potential to improve treatment outcomes. Adherence to topical treatment tends to improve around the time of office visits (so called, "white coat compliance"), much as tooth flossing behavior improves around the time of dental visits. Standard-of-care treatment of atopic dermatitis generally involves having patients return in roughly 4 weeks to assess treatment efficacy. Clinical trials generally have more frequent visits. The investigator's recent studies have suggested that adherence may be improved with virtual medical visits, alleviating the need for more frequent in-person office visits that can be costly and negatively impact access to care.
- Conditions
- Mild to Moderate Atopic Dermatitis
- Being tested
- Online Treatment response, EUCRISA
- Keywords
- topical therapy, atopic dermatitis,
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Treatment responseBehavioural
Electronic treatment response survey to track use of study medication, EUCRISA (crisaborole) ointment 2%.
EUCRISADrug
Participants are given EUCRISA (crisaborole) ointment 2%.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard of Care | Active comparator | Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and follow standard of care Receives: Drug: EUCRISA |
| Arm 2 - Online Treatment Response | Experimental | Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and electronic treatment response emails Receives: Behavioral: Online Treatment response; Drug: EUCRISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to topical Therapy
Difference in adherence between standard-of-care and intervention with use of the impact of an internet reporting intervention on adherence. Asking 50% of the enrolled subjects to complete internet-based surveys on their use of the study medication.
Measured: 12 months
Secondary outcomes (4)
Adherence to topical therapy #1
Difference in adherence between standard-of-care and intervention with use of MEMS Caps: The Medical Events Monitoring System (MEMS) by MWV formerly Aardex Corporation in Switzerland will be used. The MEMS incorporates a microprocessor into the cap of a standard medication tube. Each time the tube is opened for at least 3 seconds, the time and date are recorded. The Eucrisa 2% ointment will be fitted with a MEMS cap using a specially designed adaptor. Subjects will be asked to bring the unused portion of the medication tube to each visit so that the medication can be "checked and redispensed". At each visit the information is downloaded via the MEMS communicator onto a computer database by the study staff to ensure the blinding of the primary physician performing the severity measures.
Measured: 12 months
Adherence to topical therapy #2
Difference in adherence between standard-of-care and intervention with use of Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is a commonly used and well-validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72.
Measured: 12 months
Adherence to topical therapy #3
Difference in adherence between standard-of-care and intervention with use Visual Analog Scale (VAS) for Itching. A 100mm VAS will be used to measure itch intensity at each visit. VAS is a self-report tool that is designed to present to the respondent a rating scale with minimum constraints. VAS data is recorded as the number of mm from the left of the line with the range 0-100mm. The Visual Analog Scale is anchored with the verbal descriptions of "no itching" on the left and "the most intense itching imaginable" on the right. VAS is considered a useful tool for the measurement of symptoms such as itch.
Measured: 12 months
Adherence to topical therapy #4
difference in adherence between the standard-of-care and intervention with use of the Investigator Global Assessment(IGA) This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Oct 2017
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will receive study medication. Groups will be randomized to receive online treatment response surveys.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay C Strowd, MD, FAAD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250663
- Sponsor's protocol ID
- IRB00045841
- Status last verified
- May 2025
- First submitted
- 4 Aug 2017
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study team does not plan to make individual participant data available; only the total outcome
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eucrisa for Atopic Dermatitis: Measuring and Improving Adherence to Topical Eucrisa in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03250663
- Acronym / sponsor ID
- IRB00045841
- Conditions
- Mild to Moderate Atopic Dermatitis
- Keywords
- topical therapy, atopic dermatitis,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 16 Aug 2017 (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.
Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software.
Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter.
The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD.
Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session).
At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.
Detailed description
Atopic Dermatitis (AD) affects between 10% and 30% of all children, making it one of the most common childhood diseases. Recent epidemiological studies report a trend toward the increasing prevalence of AD in children. Symptoms of AD include dry, scaly, and intensely itchy skin. A number of treatments are available for these patients. Topical corticosteroids are commonly prescribed. Topical immunomodulators without the potential for steroid atrophy are also used. A non-steroidal topical, Eucrisa (crisaborole) ointment, is specifically indicated for mild to moderate atopic dermatitis and was approved for marketing in the U.S. for the treatment atopic dermatitis in December 2016. The 2% ointment is approved for use in patients ages 2 and older. Unfortunately, many people with atopic dermatitis do not adequately respond to topical treatment.
It is widely recognized that adherence to oral medications is poor. Adherence to medication in chronic disease is worse. Adherence to topical medication for chronic disease in children is horrible. In a previous study, the investigator found that the adherence of children to topical triamcinolone for atopic dermatitis was poor. Adherence dropped by roughly 60-70% over the first 3 days of treatment. While that study analyzed adherence over 8 weeks, the long-term adherence to topical treatment in patients with atopic dermatitis is not well characterized.
Measures to improve adherence have the potential to improve treatment outcomes. Adherence to topical treatment tends to improve around the time of office visits (so called, "white coat compliance"), much as tooth flossing behavior improves around the time of dental visits. Standard-of-care treatment of atopic dermatitis generally involves having patients return in roughly 4 weeks to assess treatment efficacy. Clinical trials generally have more frequent visits. The investigator's recent studies have suggested that adherence may be improved with virtual medical visits, alleviating the need for more frequent in-person office visits that can be costly and negatively impact access to care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All subjects will receive study medication. Groups will be randomized to receive online treatment response surveys.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard of Care | Active comparator | Drug: EUCRISASubjects receive study medication, EUCRISA (crisaborole) ointment 2%, and follow standard of care |
| Arm 2 - Online Treatment Response | Experimental | Behavioral: Online Treatment response, Drug: EUCRISASubjects receive study medication, EUCRISA (crisaborole) ointment 2%, and electronic treatment response emails |
Who may qualify
- Ages
- 2 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female subjects age 2-64.
- Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.
Key exclusion criteria (6 listed)
- Known allergy to crisaborole or to any component of the formulations.
- The use of systemic therapy for atopic dermatitis within the past 4 weeks.
- Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
- Use of any investigational therapy within the past 4 weeks.
- Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at 6 month and 12 month.
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 |
|---|---|---|
| Online Treatment responseElectronic treatment response survey to track use of study medication, EUCRISA (crisaborole) ointment 2%. | Behavioural | Arm 2 - Online Treatment Response |
| EUCRISAParticipants are given EUCRISA (crisaborole) ointment 2%. | Drug | Arm 1 - Standard of Care, Arm 2 - Online Treatment Response |
Primary outcome
Adherence to topical Therapy
Time frame: 12 months
Difference in adherence between standard-of-care and intervention with use of the impact of an internet reporting intervention on adherence. Asking 50% of the enrolled subjects to complete internet-based surveys on their use of the study medication.
4 secondary outcomes
Adherence to topical therapy #1
Time frame: 12 months
Adherence to topical therapy #2
Time frame: 12 months
Adherence to topical therapy #3
Time frame: 12 months
Adherence to topical therapy #4
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No. Study team does not plan to make individual participant data available; only the total outcome
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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. This study is not recruiting at the moment.
Lindsay C Strowd, MD, FAAD 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 Phase 1 study testing Online Treatment response and EUCRISA in people with Mild to Moderate 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Jul 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to topical Therapy (time frame: 12 months). 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 2 Jul 2025.