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 ]

Blinded observer and patient will separately quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. The time to reach each grade for each area of evaluated skin will be evaluated for the pooled patients and reported as "medium time to reach level [0,1,2,3,4]" Timing for areas treated with Difinsa53 versus Aquaphor will be compared using paired T-test.


Original Primary Outcome: Same as current

Current Secondary Outcome: Photographic evaluation of skin changes [ Time Frame: 18 months ]

Photographic data will be analyzed by a blinded observer(s) to assess the dermal layer effect at a micro-3D level, trained by the Canfield team for use of the software provided with their camera. This will include quantifying maximum erythema for treated (Difinsa53) and control (Aquaphor) fields on a weekly basis by measuring optical reflectance at various wave lengths. Pooled data will be compared using a paired T-test.


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