A Substantial Equivalence Study of RD04723 and Predicate Device

Not Applicable

• Conditions: Hypertrophic Scar; Keloid Scar

• 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

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