Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis

Exclusion Criteria

• •Known uncontrolled diabetes
• •Prior radiation to breast
• •Known connective tissue disorder
• •Known skin disease over the treated breast
• •Prior burn over treated area
• •Evidence of infection or inflammation of breast to be treated.
• •Receiving biological therapy or hormone therapy (other than Herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
• •Pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
• •Pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the Investigator.
• •Participation in another investigational drug or vaccine trial concurrently or within 30 days.
• •Use of any other topical or systemic treatments aimed at radiation dermatitis.
• •Use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation