Status:
COMPLETED
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated...
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.
- Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at Baseline.
- Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles.
- Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical Lesion ISGA score of greater than/equal to 3.
Exclusion
- Clinically infected AD or requires high potency topical corticosteroids or systemic (oral/injectable) corticosteroids to manage AD.
- History of angioedema or anaphylaxis to topical products or known sensitivity to components of crisaborole ointment 2%.
- History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the skin).
- Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the reason of lack of efficacy.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03233529
Start Date
July 31 2017
End Date
May 4 2018
Last Update
August 13 2019
Active Locations (1)
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1
Innovaderm Research Incorporated
Montreal, Quebec, Canada, H2K 4L5