Eucrisa for Atopic Dermatitis
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 2 - 64 |
| Updated: | 7/18/2018 |
| Start Date: | October 1, 2017 |
| End Date: | August 1, 2019 |
| Contact: | Irma M Richardson, MHA |
| Email: | irichard@wakehealth.edu |
| Phone: | 336-716-2903 |
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.
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.
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.
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.
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.
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.
We found this trial at
1
site
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
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