NCT00432185 - 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)

Gross K, Schmieder GJ, Tu J
Maximum Tolerated Dose and Safety of PEP005 (ingenol mebutate) Gel for Topical Treatment of Superficial Basal Cell Carcinoma. Summer Academy, American Academy of Dermatology meeting, Boston, MA, 2009. 2009: Poster no. 1902 (31
Gross K
Safety and efficacy of ingenol mebutate (PEP005) gel for topical treatment of superficial basal cell carcinoma. J Am Acad Dermatol 2009; 60(3, Suppl. 1): AB141; P2928

An Open-label, Multi-center, Dose-escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Given as Either a Single Application (on Day 1) or as Two Applications (on Day 1 and Day 8) to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk.

Details for clinical trial NCT00432185

Clinical trial NCT00432185 - References