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A Substantial Equivalence Study of RD04723 and Predicate Device

NCT01736969 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-12-03

No results posted yet for this study

Summary

The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.

Conditions

  • Hypertrophic Scar
  • Keloid Scar

Interventions

DEVICE

RD047-023

Experimental hydrogel

DEVICE

Predicate Device

Sponsors & Collaborators

  • Oculus Innovative Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Janet C DuBois, MD · Derm Research, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-03-31

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 NCT01736969 on ClinicalTrials.gov