ScarsNCT03782038
Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars
A study testing MCD in people with Scars, run by Cytrellis Biosystems, Inc. at 1 site in United States.
Trial summary
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- MCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Fitzpatrick scale I-VI.
- Any type of scar except for keloid scars
- Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.
Who cannot join
- Previous treatment of the scar tissue within last 6 months.
- Silicone, fat, collagen or synthetic material in the treatment area.
- History of keloid formation.
- Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.
- Active, chronic, or recurrent infection.
- Compromised immune system (e.g. diabetes).
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- Hypersensitivity to analgesic agents.
- Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
- Pregnant or breastfeeding.
- Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation.
- Any medication that may cause bleeding such as anticoagulants.
- Allergy to lidocaine and/or epinephrine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Miami Dermatology & Laser Institute
Miami, Florida, 33173
Nicole Rieth, 305-279-6060, nicoler@miamidermlaser.com
About this study
Official title: A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
Read the detailed description
The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment.
An study results will be assessed on the following:
- POSAS - Patient Observer Scar Assessment
- ASAS - Acne Scar Severity Scale
- Subject Satisfaction Scale
- Conditions
- Scars
- Being tested
- MCD
- Keywords
- Acne Scars, Stretchmarks, Surgical Scars
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCDDevice
Micro coring skin removal with automated coring device
| Study group | Role | What they receive |
|---|---|---|
| Micro-coring of scars with MCD | Experimental | Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD. Receives: Device: MCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.
Measured: 6 months post last treatment
Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4
Measured: 6 months post last treatment
Secondary outcomes (1)
Assess safety profile by recording all adverse events reported during study
Adverse events will be recorded throughout the study
Measured: 6 months post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start13 Sep 2018
- Primary completion17 Sep 2019 (estimated)
- Study completion21 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782038
- Sponsor's protocol ID
- AIS 700-00053
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
- ClinicalTrials.gov ID
- NCT03782038
- Acronym / sponsor ID
- AIS 700-00053
- Conditions
- Scars
- Keywords
- Acne Scars, Stretchmarks, Surgical Scars
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 17 Sep 2019 (estimated)
- Study completion
- 21 Nov 2019 (estimated)
- First posted
- 20 Dec 2018 (actual)
- 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.
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
Detailed description
The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment.
An study results will be assessed on the following:
- POSAS - Patient Observer Scar Assessment
- ASAS - Acne Scar Severity Scale
- Subject Satisfaction Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro-coring of scars with MCD | Experimental | Device: MCDMicro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last treatment with MCD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Fitzpatrick scale I-VI.
- Any type of scar except for keloid scars
- Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.
Key exclusion criteria (12 listed)
- Previous treatment of the scar tissue within last 6 months.
- Silicone, fat, collagen or synthetic material in the treatment area.
- History of keloid formation.
- Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.
- Active, chronic, or recurrent infection.
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 |
|---|---|---|
| MCDMicro coring skin removal with automated coring device | Device | Micro-coring of scars with MCD |
Primary outcome
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
Time frame: 6 months post last treatment
Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.
Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
Time frame: 6 months post last treatment
Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4
1 secondary outcome
Assess safety profile by recording all adverse events reported during study
Time frame: 6 months post last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCD in people with Scars, run by Cytrellis Biosystems, 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Dec 2018. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess level of aesthetic improvement using POSAS scale 6 months post last treatment (time frame: 6 months post last treatment). The study lists 2 primary outcomes in all. 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 21 Dec 2018.