Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin
cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment,
Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or
mastectomy surgery. Presently there is no known fully effective topical protectant from RD
and there is no consensus among radiation oncologists on how best to treat RD. This study
seeks to identify a more effective option for patients receiving radiation therapy. Each
participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to
another area of treated skin. Skin reactions will be evaluated using medical professional
assessment, participant assessment, and photographic assessment by a third party.

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