Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02534129
Study type	Interventional
Source	ProTechSure Scientific, Inc.
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	August 2015
Completion date	March 2016

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See also
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