NCT01714973

Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.

Conditions

• Radiation-induced Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	ST266	Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-07-01
• Completion: 2015-10-01
• First posted: 2012-10-26
• Last updated: 2019-05-13

Locations

1 site across 1 country: United States