NCT00108121 - 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)

Rosen RH, Freeman M, Siller G, Katsamas J, Ogbourne SM
Safety and efficacy of PEP005 Topical Gel for the treatment of nodular and superficial forms of basal cell carcinoma. Summer Academy, American Academy of Dermatology meeting, New York, NY, 2007. 2007
Rosen RH, Katsamas J, Ogbourne SM, Welburn P
Early phase clinical development of PEP005 topical gel for basal cell carcinoma. 21st World Congress of Dermatology, Buenos Aires, 2007. 2007: Poster no. P5755 (1 p.)

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Nodular Basal Cell Carcinoma

Details for clinical trial NCT00108121

Clinical trial NCT00108121 - References