A Substantial Equivalence Study of RD04723 and Predicate Device

Not Applicable

• Conditions: Hypertrophic Scar; Keloid Scar
• Interventions: Device: RD047-023; Device: Predicate Device

• Registration Number: NCT01736969
• Lead Sponsor: Oculus Innovative Sciences, Inc.

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 available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-12
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RD047-023	RD047-023	RD-047-023
Predicate Device	Predicate Device	legally marketed predicate device

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain and itch	4 weeks, 8 weeks, 12 weeks	Patient assessment of pain and itch. Scoring from 0-3.
Adverse Events	Baseline, Weeks: 2, 4, 8, 12 and early termination	Number of subjects with related adverse events
Treatment satisfaction	8 weeks, 12 weeks	Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".

Trial Locations

Locations (1)

DermResearch Inc; 🇺🇸 Austin, Texas, United States