WrinkleNCT06502470
Healing Study of Fractional Skin Resurfacing and Tissue Histopathology After Ellacor Treatment
A study testing ellacor® Micro-Coring procedure in people with Wrinkle and Rhytides, run by Cytrellis Biosystems, Inc. at 1 site in United States.
Trial summary
The goal of this study is to observe the healing of skin after ellacor® treatment at different timepoints, depths and coring densities. The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor® procedure works to induce skin resurfacing using an abdominoplasty, or… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Rhytides, Histopathology
- What is being tested?
- ellacor® Micro-Coring procedure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 17 May 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing planned abdominoplasty
- Are willing to donate their tissue for evaluation
- BMI ≤ 30
- Women 18 years or older
- Fitzpatrick scale I-VI
- Females of childbearing potential will have a negative urine pregnancy test prior to each procedure
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- Are judged to be in good health based on the results of a medical history and physical examination (standard of care for abdominoplasty) at screening
- Has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the IRB of the respective clinical site.
- Able and willing to comply with all visits, procedures and evaluation schedules and requirements
Who cannot join
- Having an active bleeding disorder or currently taking anticoagulants
- History of keloid formation or abnormal wound healing
- Inflammation or active infection and treatment area
- Compromised immune system (e.g., diabetes)
- Any surgery or treatments in the abdominal area 12 months prior to procedure
- Comorbid condition that could limit ability to participate in the study or to comply with follow up requirements
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- Pregnant or breastfeeding
- Tattoo and/or mole located within the planned treatment area(s)
- Vulnerable populations include those defined 45 CFR 46 Subparts B, and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons
- Any issue that at the discretion of the investigator would contraindicate the subject's participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
About this study
Official title: Open Label Study to Explore Healing and Tissue Histopathology Following Ellacor Micro-Coring Procedures in an Abdominoplasty Model
The goal of this study is to observe the healing of skin after ellacor® treatment at different timepoints, depths and coring densities. The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor® procedure works to induce skin resurfacing using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure.
The main questions this study aims to answer are:
Read more
How does human skin change after a series of the ellacor® procedures over a 14-day period?
Is the ellacor® device safe to use at different treatment time points, depths and densities?
The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the skin areas marked for removal during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in the study.
The 3 participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study.
Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated, which is the control area. This will reveal, by visual comparison, any changes in the skin tissue between treated and untreated areas, if they occur.
- Conditions
- Wrinkle, Rhytides, Histopathology
- Being tested
- ellacor® Micro-Coring procedure
- Keywords
- Mechanism of Healing, Micro-Coring, Abdominoplasty, Histopathology, Immunohistochemistry, Wrinkle treatment, Fractional Skin Resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ellacor® Micro-Coring procedureDevice
ellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.
| Study group | Role | What they receive |
|---|---|---|
| Safety Evaluation of Skin Removal Percentages and Evaluation of Healing over 14 Days. | Experimental | Three participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using different skin removal percent settings: 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study. Receives: Device: ellacor® Micro-Coring procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
The incidence and severity of adverse events will be evaluated for all subjects enrolled to the study.
Measured: Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 14 for all subjects).
The change in histopathology of abdominoplasty tissue samples after sequential treatments with the ellacor® device at a micro-coring depth of 7mm over a 14-day period as compared to an untreated control area.
This 14-day healing evaluation of fractional skin resurfacing will compare the histopathology of stained tissue isolated after sequential ellacor® treatments on abdominal skin tissue. The samples will be isolated from excised abdominal tissue following abdominoplasty. The tissue will include an untreated control area compared to three ellacor® treated areas with depth of treatment at 7mm and different tissue percentage removal settings. Area 1 = 5% tissue removal, Area 2 = 7% and Area 3 = 8%. Each area will be treated on Day -14, Day -7, Day -3 and Day 0, the day of abdominoplasty. Histopathological evaluation will include Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The stains will provide comparison of structural tissue changes (H\&E stain), change in presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in presence of collagen, fibrin and elastic fibers (Movat stain) over the 14-day time period compared to untreated control area.
Measured: The abdominoplasty tissue will be excised 14 days after the initial ellacor® treatment. Histopathological studies will be performed upon receipt at the central pathology laboratory.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start30 Apr 2024
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Abdominoplasty model
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dallas Plastic Surgery Institute
- Responsible party
- Sponsor
- Investigators
- Jill Edgecombe, Study director, Cytrellis Biosystems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502470
- Sponsor's protocol ID
- TP-00437
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- 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 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Explore Healing and Tissue Histopathology Following Ellacor Micro-Coring Procedures in an Abdominoplasty Model
- ClinicalTrials.gov ID
- NCT06502470
- Acronym / sponsor ID
- TP-00437
- Conditions
- Wrinkle, Rhytides, Histopathology
- Keywords
- Mechanism of Healing, Micro-Coring, Abdominoplasty, Histopathology, Immunohistochemistry, Wrinkle treatment, Fractional Skin Resurfacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dallas Plastic Surgery Institute
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 16 Jul 2024 (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.
The goal of this study is to observe the healing of skin after ellacor® treatment at different timepoints, depths and coring densities. The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor® procedure works to induce skin resurfacing using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure.
The main questions this study aims to answer are:
How does human skin change after a series of the ellacor® procedures over a 14-day period?
Is the ellacor® device safe to use at different treatment time points, depths and densities?
The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the skin areas marked for removal during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in the study.
The 3 participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study.
Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated, which is the control area. This will reveal, by visual comparison, any changes in the skin tissue between treated and untreated areas, if they occur.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Abdominoplasty model
| Arm | Type | Receives |
|---|---|---|
| Safety Evaluation of Skin Removal Percentages and Evaluation of Healing over 14 Days. | Experimental | Device: ellacor® Micro-Coring procedureThree participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using different skin removal percent settings: 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Undergoing planned abdominoplasty
- Are willing to donate their tissue for evaluation
- BMI ≤ 30
- Women 18 years or older
- Fitzpatrick scale I-VI
Key exclusion criteria (10 listed)
- Having an active bleeding disorder or currently taking anticoagulants
- History of keloid formation or abnormal wound healing
- Inflammation or active infection and treatment area
- Compromised immune system (e.g., diabetes)
- Any surgery or treatments in the abdominal area 12 months prior to procedure
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 |
|---|---|---|
| ellacor® Micro-Coring procedureellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. | Device | Safety Evaluation of Skin Removal Percentages and Evaluation of Healing over 14 Days. |
Primary outcome
Incidence and severity of adverse events
Time frame: Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 14 for all subjects).
The incidence and severity of adverse events will be evaluated for all subjects enrolled to the study.
The change in histopathology of abdominoplasty tissue samples after sequential treatments with the ellacor® device at a micro-coring depth of 7mm over a 14-day period as compared to an untreated control area.
Time frame: The abdominoplasty tissue will be excised 14 days after the initial ellacor® treatment. Histopathological studies will be performed upon receipt at the central pathology laboratory.
This 14-day healing evaluation of fractional skin resurfacing will compare the histopathology of stained tissue isolated after sequential ellacor® treatments on abdominal skin tissue. The samples will be isolated from excised abdominal tissue following abdominoplasty. The tissue will include an untreated control area compared to three ellacor® treated areas with depth of treatment at 7mm and different tissue percentage removal settings. Area 1 = 5% tissue removal, Area 2 = 7% and Area 3 = 8%. Each area will be treated on Day -14, Day -7, Day -3 and Day 0, the day of abdominoplasty. Histopathological evaluation will include Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The stains will provide comparison of structural tissue changes (H\&E stain), change in presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in presence of collagen, fibrin and elastic fibers (Movat stain) over the 14-day time period compared to untreated control area.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Jill Edgecombe study director
Cytrellis Biosystems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ellacor® Micro-Coring procedure in people with Wrinkle and Rhytides, 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 16 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events (time frame: Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 14 for all subjects).). 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 16 Jul 2024.