A Substantial Equivalence Study of RD04723 and Predicate Device

Oculus Innovative Sciences, Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertrophic Scar Keloid Scar

Interventions

RD047-023DEVICE

Experimental hydrogel

Predicate DeviceDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

DermResearch Inc

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes

Pain and itch

Patient assessment of pain and itch. Scoring from 0-3.

Time frame: 4 weeks, 8 weeks, 12 weeks

Adverse Events

Number of subjects with related adverse events

Time frame: Baseline, Weeks: 2, 4, 8, 12 and early termination

Treatment satisfaction

Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".

Time frame: 8 weeks, 12 weeks

Data from ClinicalTrials.gov

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