Sinecatechins is a botanical drug product for topical use. It is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.
For the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
Bethesda North Hospital, Cincinnati, Ohio, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States
CardioSec Clinical Reasearch GmbH, Erfurt, Germany
LSu Health Sciences Center, New Orleans, Louisiana, United States
University of Texas Health Science Center Houston, Houston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
The University of Chicago, Chicago, Illinois, United States
Louisiana Health Sciences Center New Orleans, New Orleans, Louisiana, United States
LSUHSC-Shreveport, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States
LSU Health Sciences Center, Shreveport, Louisiana, United States
Columbia Presbyterian Hospital, New York, New York, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States
Jefferson Medical College - Department of Urology, Philadelphia, Pennsylvania, United States
University of Chicago - Department of Surgery, Chicago, Illinois, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea, Tucson, Arizona, United States
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