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Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

NCT02534129 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-10-06

Study results available
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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.

Conditions

  • Radiodermatitis

Interventions

DRUG

Difinsa53

Difinsa53 cream is applied to one half of radiation field

DRUG

Aquaphor

Aquaphor is applied to one half of radiation field

Sponsors & Collaborators

  • Poudre Valley Health System

    collaborator OTHER

  • ProTechSure Scientific, Inc.

    lead INDUSTRY

Principal Investigators

  • Joshua Petit, MD · UC Health, Poudre Valley Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT02534129 on ClinicalTrials.gov