HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer

Summary

This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.

Timeline

Start

2012-08

Primary completion

2015-11

Completion

2015-12

Outcome

Missed primary endpoint

paper On physician's evaluation, there was no significant difference in radiation dermatitis between S and P PMID 31273506 ↗

Publications

• Rahimi A, Mohamad O, Albuquerque K, Kim DWN, Chen D, Thomas K, Wooldridge R, Rivers A, Leitch M, Rao R, Haley B, Ahn C, Garwood D, Spangler A. Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1481-1489. doi: 10.1007/s00520-019-04957-0. Epub 2019 Jul 4.

Drugs

Indications