Status:
COMPLETED
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Collaborating Sponsors:
WAYCro
Conditions:
Bioequivalence Study
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
Eligibility Criteria
Inclusion
- Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;
Exclusion
- Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
- History of hypersensitivity to the study products or any topical or systemic corticosteroids;
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2018
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04358770
Start Date
March 2 2018
End Date
May 11 2018
Last Update
April 24 2020
Active Locations (1)
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1
WayCro
Dallas, Texas, United States, 75234