CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
HylaCare +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02165605
NCT02165605N/ACompleted
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Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.

University of Texas Southwestern Medical Center·interventional·Posted Jun 17, 2014·Updated Oct 22, 2020

In Brief

A clinical study evaluating HylaCare and Placebo for Breast Cancer. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2014
Enrollment StartAug 1, 2012
Primary CompletionNov 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.0 years ago

Interventions

HylaCaredrug

cream

Placebodrug

placebo