A Substantial Equivalence Study of RD04723 and Predicate... | NCT01736969

Studies
A Substantial Equivalence Study of RD04723 and Predicate Device

NCT01736969

Sponsor

Oculus Innovative Sciences, Inc.

Status

Unknown status

Last Update Posted

Dec 3, 2012Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hypertrophic Scar
Keloid Scar

Interventions

RD047-023
Predicate Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Not provided

First Submitted Date

Oct 12, 2012

First Submission Date that Met QC Criteria

Nov 26, 2012

First Posted Date

Nov 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RD047-023	Experimental	RD-047-023	Device: RD047-023
Predicate Device	Active Comparator	legally marketed predicate device	Device: Predicate Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RD047-023	Device	Experimental hydrogel	RD047-023
Predicate Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)	Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.	4 weeks, 8 weeks, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pain and itch	Patient assessment of pain and itch. Scoring from 0-3.	4 weeks, 8 weeks, 12 weeks
Adverse Events	Number of subjects with related adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janet C DuBois, MD	Derm Research, PLLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DermResearch Inc		Austin	Texas	78759	United States

Type	Date	Date Unknown
Release	Apr 10, 2018
Reset	May 11, 2018
Release	May 16, 2018
Reset	Jun 14, 2018
Release	Jun 15, 2018
Reset	Jul 12, 2018
Release	Aug 30, 2019
Reset	Sep 23, 2019

Submission Tracking

Estimated Results First Submitted Date

Apr 10, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 10, 2018			May 11, 2018
May 16, 2018

Condition Browse Module

MeSH Terms

ID	Term
D017439	Cicatrix, Hypertrophic
D007627	Keloid

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided