Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03250663
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2017-08-04
Brief Title:
Eucrisa for Atopic Dermatitis
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Eucrisa for Atopic Dermatitis Measuring and Improving Adherence to Topical Eucrisa in Patients With Atopic Dermatitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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
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 subjects 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 US 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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None