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Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

NCT01714973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-05-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Noveome Biotherapeutics, formerly Stemnion

    lead INDUSTRY

Principal Investigators

  • Mark Trombetta, MD · West Penn Allegheny Health System

  • David L Steed, MD · Noveome Biotherapeutics, formerly Stemnion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-07-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01714973 on ClinicalTrials.gov