458
Participants
Start Date
March 1, 2022
Primary Completion Date
November 1, 2022
Study Completion Date
December 1, 2022
Test Product (A): Fluorouracil Cream, 5% topical cream
Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India
Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
CBCC Global Research Site 007, Sugarloaf
CBCC Global Research Site 001, Miami
CBCC Global Research Site 003, Miramar
CBCC Global Research Site 002, Miami
CBCC Global Research Site 004, Lauderdale Lakes
CBCC Global Research Site 006, Cerritos
CBCC Global Research Site 005, Bakersfield
Lead Sponsor
Collaborators (1)
CBCC Global Research
NETWORK
Encube Ethicals Pvt. Ltd.
INDUSTRY