Hypertrophic ScarNCT01736969
A Substantial Equivalence Study of RD04723 and Predicate Device
A study testing RD047-023 and Predicate Device in people with Hypertrophic Scar and Keloid Scar, run by Oculus Innovative Sciences, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Scar, Keloid Scar
- What is being tested?
- RD047-023 and Predicate Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
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
- Hypertrophic Scar, Keloid Scar
- Being tested
- RD047-023, Predicate Device
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD047-023Device
Experimental hydrogel
Predicate DeviceDevice
Also called Kelo-Cote
| Study group | Role | What they receive |
|---|---|---|
| RD047-023 | Experimental | RD-047-023 Receives: Device: RD047-023 |
| Predicate Device | Active comparator | legally marketed predicate device Receives: Device: Predicate Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (3)
Pain and itch
Patient assessment of pain and itch. Scoring from 0-3.
Measured: 4 weeks, 8 weeks, 12 weeks
Adverse Events
Number of subjects with related adverse events
Measured: 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".
Measured: 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oculus Innovative Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet C DuBois, MD, Principal investigator, Derm Research, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736969
- Sponsor's protocol ID
- MSM-RD-023
- Status last verified
- Nov 2012
- First submitted
- 12 Oct 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
- ClinicalTrials.gov ID
- NCT01736969
- Acronym / sponsor ID
- MSM-RD-023
- Conditions
- Hypertrophic Scar, Keloid Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oculus Innovative Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (estimated)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RD047-023 | Experimental | Device: RD047-023RD-047-023 |
| Predicate Device | Active comparator | Device: Predicate Devicelegally marketed predicate device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD047-023Experimental hydrogel | Device | RD047-023 |
| Predicate DeviceAlso: Kelo-Cote | Device | Predicate Device |
Primary outcome
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
Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.
3 secondary outcomes
Pain and itch
Time frame: 4 weeks, 8 weeks, 12 weeks
Adverse Events
Time frame: Baseline, Weeks: 2, 4, 8, 12 and early termination
Treatment satisfaction
Time frame: 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet C DuBois, MD principal investigator
Derm Research, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD047-023 and Predicate Device in people with Hypertrophic Scar and Keloid Scar, run by Oculus Innovative Sciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.