Trials / Unknown
UnknownNCT01736969
A Substantial Equivalence Study of RD04723 and Predicate Device
Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Oculus Innovative Sciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RD047-023 | Experimental hydrogel |
| DEVICE | Predicate Device |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2013-03-01
- First posted
- 2012-11-29
- Last updated
- 2012-12-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01736969. Inclusion in this directory is not an endorsement.