Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ProTechSure Scientific, Inc.
• Collaborator: Poudre Valley Health System
• Treatments: Petrolatum

Criteria

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