Status:
COMPLETED
Eucrisa for Atopic Dermatitis
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Mild to Moderate Atopic Dermatitis
Eligibility:
All Genders
2-64 years
Phase:
PHASE1
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 tha...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03250663
Start Date
October 1 2017
End Date
July 27 2022
Last Update
July 2 2025
Active Locations (1)
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1
Wake Forest University Heath Sciences
Winston-Salem, North Carolina, United States, 27157