A Substantial Equivalence Study of RD04723 and Predicate Device
This study is ongoing, but not recruiting participants.
Sponsor:
Oculus Innovative Sciences, Inc.
Information provided by (Responsible Party):
Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01736969
First received: October 12, 2012
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertrophic Scar Keloid Scar |
Device: RD047-023 Device: Predicate Device |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars |
Resource links provided by NLM:
Further study details as provided by Oculus Innovative Sciences, Inc.:
Primary Outcome Measures:
- Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination) [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
Secondary Outcome Measures:
- Pain and itch [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]Patient assessment of pain and itch. Scoring from 0-3.
- Adverse Events [ Time Frame: Baseline, Weeks: 2, 4, 8, 12 and early termination ] [ Designated as safety issue: No ]Number of subjects with related adverse events
- Treatment satisfaction [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RD047-023
RD-047-023
|
Device: RD047-023
Experimental hydrogel
|
|
Active Comparator: Predicate Device
legally marketed predicate device
|
Device: Predicate Device
Other Name: Kelo-Cote
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Oculus Innovative Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01736969 History of Changes |
| Other Study ID Numbers: | MSM-RD-023 |
| Study First Received: | October 12, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hypertrophy Keloid Cicatrix, Hypertrophic Cicatrix Pathological Conditions, Anatomical |
Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013