A Substantial Equivalence Study of RD04723 and Predicate Device
NCT ID: NCT01736969
Last Updated: 2012-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RD047-023
RD-047-023
RD047-023
Experimental hydrogel
Predicate Device
legally marketed predicate device
Predicate Device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RD047-023
Experimental hydrogel
Predicate Device
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oculus Innovative Sciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janet C DuBois, MD
Role: PRINCIPAL_INVESTIGATOR
Derm Research, PLLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
DermResearch Inc
Austin, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MSM-RD-023
Identifier Type: -
Identifier Source: org_study_id