Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Stopped early · Phase 1/Phase 2

Conditions studied: Radiodermatitis

In brief

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.

Key facts

Study ID

NCT02534129

Run by

ProTechSure Scientific, Inc.

People needed

13

Starts

2015-08-01

Expected to finish

2016-03-01

Last updated by the study team

2017-10-06

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Poudre Valley Health System — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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