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Eucrisa for Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03250663
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Mild to Moderate Atopic Dermatitis Behavioral: Online Treatment response Drug: EUCRISA Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects will receive study medication. Groups will be randomized to receive online treatment response surveys.
Masking: Double (Participant, Investigator)
Masking Description: adherence data of the randomized subjects
Primary Purpose: Health Services Research
Official Title: Eucrisa for Atopic Dermatitis: Measuring and Improving Adherence to Topical Eucrisa in Patients With Atopic Dermatitis
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Arm 1 - Standard of Care
Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and follow standard of care
Drug: EUCRISA
Participants are given EUCRISA (crisaborole) ointment 2%.

Experimental: Arm 2 - Online Treatment Response
Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and electronic treatment response emails
Behavioral: Online Treatment response
Electronic treatment response survey to track use of study medication, EUCRISA (crisaborole) ointment 2%.

Drug: EUCRISA
Participants are given EUCRISA (crisaborole) ointment 2%.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adherence to topical therapy #1 [ Time Frame: 12 months ]
    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.

  2. Adherence to topical therapy #2 [ Time Frame: 12 months ]
    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.

  3. Adherence to topical therapy #3 [ Time Frame: 12 months ]
    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.

  4. Adherence to topical therapy #4 [ Time Frame: 12 months ]
    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



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Ages Eligible for Study:   2 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250663


Contacts
Contact: Irma M Richardson, MHA 336-716-2903 irichard@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Heath Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Lindsay C Strowd, MD, FAAD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03250663     History of Changes
Other Study ID Numbers: IRB00045841
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study team does not plan to make individual participant data available; only the total outcome

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Wake Forest University Health Sciences:
topical therapy, atopic dermatitis,

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases