A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Summary
This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2009-04
- Primary completion
- 2012-06
- Completion
- 2012-06
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Fisiogel; p = 0.481; t-test, 1 sided NCT00718315 ↗
registry analysis (superiority or other test); Stiemicyn; p = 0.933; t-test, 1 sided NCT00718315 ↗
registry analysis (superiority or other test); Verutex; p = 0.986; t-test, 1 sided NCT00718315 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erythromycin | Small molecule | — | Topical |
| Subject | Fisiogel | Unknown | — | Topical |
| Subject | Fusidic Acid | Unknown | — | Topical |
| Background | Erlotinib | Small molecule | 150 mg | Oral |