A Substantial Equivalence Study of RD04723 and Predicate Device

Status unconfirmed · Not applicable

Conditions studied: Hypertrophic Scar, Keloid Scar

In brief

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.

Key facts

Study ID

NCT01736969

Run by

Oculus Innovative Sciences, Inc.

People needed

40

Starts

2012-08-01

Last updated by the study team

2012-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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)

Where it is running

• DermResearch Inc — Austin, Texas, United States

Full record on ClinicalTrials.gov

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