Status:
COMPLETED
Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Innovaderm Research Inc.
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic derm...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to screening and that has been clinically stable for 1 month.
- Has four application areas of 3 cm in diameter with a TSS of ≥5 and TAA of moderate at Day 1. The application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. The application areas should be ≥1 cm apart.
Exclusion
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Subject has clinically infected AD.
- Subject has a Fitzpatrick's Skin Phototype ≥5.
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.
- Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- Subject has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
- Subject with a known lack of efficacy to crisaborole.
- Subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container.
- Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03868098
Start Date
May 21 2019
End Date
November 25 2020
Last Update
August 24 2021
Active Locations (1)
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1
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2X 2V1