Rash Due to Epidermal Growth Factor Receptor Inhibitors Clinical Trial
Official title:
A Safety, Tolerability and Efficacy Study of Doxycycline Topical Foam Administered Topically for Prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects With Cancer Receiving Cetuximab or Panitumumab
The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.
This is a phase II multicenter, randomized, double blind, vehicle controlled clinical study
to evaluate the safety, tolerability and efficacy of Doxycycline Foam 4% for the prevention
of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects with Cancer
Receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis.
The study consists of a screening visit, a treatment period where patients will be treated
topically on the face twice daily for 5 weeks. A post-treatment follow up visit (4 weeks
after end of treatment), will be performed only for subjects who have experienced unresolved
possibly-related or related adverse events at the end of the treatment. Seven days after
randomization and study drug initiation, subjects will start their EGFRI treatment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01763307 -
A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI
|
Phase 2 |