NCT02534129

Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ProTechSure Scientific, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Radiodermatitis

Interventions

Type	Name	Description
DRUG	Difinsa53	Difinsa53 cream is applied to one half of radiation field
DRUG	Aquaphor	Aquaphor is applied to one half of radiation field

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-08-27
• Last updated: 2017-10-06
• Results posted: 2017-10-06

Locations

1 site across 1 country: United States