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

NCT02165605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-10-22

Study results available
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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.

Conditions

Interventions

DRUG

HylaCare

cream

DRUG

Placebo

placebo

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Asal Rahimi, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02165605 on ClinicalTrials.gov