Clinical Trial: Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study
Brief 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 Summary: 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.
Sponsor: ProTechSure Scientific, Inc.
Current Primary Outcome: Radiation dermatitis as determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Photographic evaluation of skin changes [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: ProTechSure Scientific, Inc.
Dates:
Date Received: August 19, 2015
Date Started: August 2015
Date Completion:
Last Updated: July 19, 2016
Last Verified: July 2016