A Substantial Equivalence Study of RD04723 and Predicate Device

Hypertrophic Scar Clinical Trial

Official title:

Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01736969
• Other study ID #: MSM-RD-023
• Status: Active, not recruiting
• Phase: N/A
• First received: October 12, 2012
• Last updated: November 30, 2012
• Start date: August 2012

Study information

• Verified date: November 2012
• Source: Oculus Innovative Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy
• Keloid
• Keloid Scar

Intervention

Device:
• RD047-023
Experimental hydrogel
• Predicate Device

Locations

Country	Name	City	State
United States	DermResearch Inc	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Oculus Innovative Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain and itch	Patient assessment of pain and itch. Scoring from 0-3.	4 weeks, 8 weeks, 12 weeks	No
Secondary	Adverse Events	Number of subjects with related adverse events	Baseline, Weeks: 2, 4, 8, 12 and early termination	No
Secondary	Treatment satisfaction	Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".	8 weeks, 12 weeks	No