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A Substantial Equivalence Study of RD04723 and Predicate Device

NCT01736969·1 site·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Oculus Innovative Sciences, Inc.

Age

18–65

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Ability to provide informed consent and release health information
Ability to follow study instructions and study requirements
Have a hypertrophic or keloid scar accessible for treatment and evaluation
Negative pregnancy test for women of childbearing potential
Agreement to use effective birth control method for study duration

You may not be if

History of allergy or sensitivity to components
History of diabetes
History of collagen vascular disorders
Anticipated need for surgery or hospitalization during the study
Pregnant, nursing, or planning a pregnancy during the study
Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

The record

StatusUnknown

PhaseNo phase

Taking part40

StartedAug 2012

UpdatedDec 3, 2012

Conditions

Hypertrophic Scar Keloid Scar

Where1

DermResearch Inc
Austin, Texas, United States

Clareo Health | A Substantial Equivalence Study of RD04723 and Predicate Device