Status:
COMPLETED
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Stasis Dermatitis
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will ...
Detailed Description
Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with...
Eligibility Criteria
Inclusion
- Participants who are ≥45 years of age and in generally stable health
- Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis
- Participants whose mental and physical status allows them to be able to mostly perform their activities of daily living with minimal assistance
Exclusion
- Participants with clinically significant active or potentially recurrent dermatitis conditions and known genetic dermatological conditions that are not Stasis Dermatitis or overlap with Stasis Dermatitis
- Participants with active venous stasis ulceration on either lower extremity.
- Participants with current infection or suspected infection of any Stasis Dermatitis lesions
- Women of child bearing potential (WOCBP) are not eligible for this study
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04091087
Start Date
June 26 2020
End Date
October 19 2021
Last Update
May 2 2022
Active Locations (4)
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1
Lightship
El Segundo, California, United States, 90245
2
Hawthorne Effect, Inc
Lafayette, California, United States, 94549
3
Verily Life Sciences LLC
South San Francisco, California, United States, 94080
4
Onco360 Oncology Pharmacy
Louisville, Kentucky, United States, 40223