Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
Sponsored by ProTechSure Scientific, Inc.
About this trial
Last updated 9 years ago
Study ID
ProTechSure 001
Status
Terminated
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
All Ages
Female
Trial Timing
Ended 10 years ago
What is this trial about?
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
What are the participation requirements?
Inclusion Criteria
* Female patients 18 years and older
* Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast
* Able to apply lotion to treatment area at least twice daily during radiation course
* All surgical sites healed
* No evidence of infection
* No history of sensitivity to any component in Aquaphor or Difensa53
Exclusion Criteria
* Prior history of radiation therapy (RT) to that site
* Known dermatologic conditions affecting skin in radiation port
* Concurrent chemotherapy
* Skin infection in radiation port
* History of sensitivity to Aquaphor or Difensa53 component