NCT00005097 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Carpenter PM, Linden KG, McLaren CE, Li KT, Arain S, Barr RJ, Hite P, Sun JD, Meyskens FL Jr
Nuclear morphometry and molecular biomarkers of actinic keratosis, sun-damaged, and nonexposed skin. Cancer Epidemiol Biomarkers Prev. 2004 Dec;13(12):1996-2002.
Linden KG, Carpenter PM, McLaren CE, Barr RJ, Hite P, Sun JD, Li KT, Viner JL, Meyskens FL
Chemoprevention of nonmelanoma skin cancer: experience with a polyphenol from green tea. Recent Results Cancer Res. 2003;163:165-71; discussion 264-6. Review.

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology

Clinical trial NCT00005097 - References