Laxity; SkinMCDNCT03583918
Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck
A study testing HighThroughput Micro Coring Device in people with Laxity; Skin, run by Cytrellis Biosystems, Inc. at 5 sites in United States.
Trial summary
This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- HighThroughput Micro Coring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2017to 13 Jun 2018
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type 1, 2, or 3 as judged by the Investigator
- Two or more of the following: Facial wrinkles assessed using the Lemperle Wrinkle Assessment Scale (descriptive and pictorial)
- Cheek fold lines >2
- Upper lip lines >3
- Nasolabial Folds >3
- Marionette lines >3
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- Labiomental crease >3
- Corner of the mouth lines >3
- Periocular lines >3
- Able to provide written informed consent, understand and willing to comply with all study related directions from investigator and follow-up visits.
Who cannot join
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone or synthetic material injections in the areas to be treated
- Injection of FDA-approved dermal fillers in the past two years
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- Injection of fat in the past year
- History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
- History of treatment with non-ablative laser in the past 6 months
- History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
- Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or currently being treated with immunosuppressive agents
- History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
- Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
- History or presence of any clinically significant bleeding disorder
- Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
- History of drug and/or alcohol abuse
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, 75231
Miami Dermatology and Laser Institute
Miami, Florida, 33173
The Practice of Brian S. Biesman, M.D
Nashville, Tennessee, 37203
Laser and Skin Surgery Center of New York
New York, New York, 10016
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Official title: A Prospective, Multi-center, Pilot Study to Evaluate the Efficacy of Micro-Excisional Skin Remodeling With Micro-Coring Device in the Treatment of Wrinkles and Skin Laxity of Face and Neck
This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.
Read the detailed description
The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent.
The subjects will be evaluated at each visit and following data will be collected:
- The incidence and severity of systemic and local adverse events.
- Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale.
- Changes in skin laxity assessed by Laxity Scale.
- Canfield Image Analyses.
- Needle and/or punch biopsy (in some subjects).
- Overall aesthetic improvement using the following scales:
- Subject and PI Global Aesthetic Improvement Scale (GAIS)
- Subject Satisfaction Scale
- Rhytides and Laxity Scale
- Lower face assessment
- Investigator evaluation of device usability and functionality. Data Analysis: Analyses will be conducted per measurement tools listed. Statistical analysis will include but will not be limited to T tests, univariate and multivariate analysis.
- Conditions
- Laxity; Skin
- Being tested
- HighThroughput Micro Coring Device
- Keywords
- facial wrinkles, skin laxity, sagging skin
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HighThroughput Micro Coring DeviceDevice
Also called skin micro-coring
Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
| Study group | Role | What they receive |
|---|---|---|
| Highthroughput Micro Coring Device | Experimental | Skin excision and removal with with Highthroughput Micro Coring device Receives: Device: HighThroughput Micro Coring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale
Assess wrinkle reduction in wrinkle severity score from the baseline assessed by Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale. No wrinkles = 0; Just perceptible wrinkles = 1; Shallow wrinkles = 2; Moderately deep wrinkles = 3; Deep wrinkles, well-defined edges = 4; Very deep wrinkles, redundant fold = 5
Measured: 90-day post-treatment
Secondary outcomes (2)
Assess skin laxity Improvement at 90 days post treatment
Improvement in skin laxity score from the baseline assessed by Independent Reviewer using Laxity Scale and supplemented by the Canfield Image Analyses. Global Aesthetic Improvement Scale: 3 Very Much Improved; 2 Much Improved; 1 Improved; 0 No Change; - 1 Worse; - 2 Much Worse; -3 Very Much Worse.
Measured: 90-day post-treatment
Assess skin for new collagenases
Histological changes in treated skin when compared to untreated skin consistent with new collagenases
Measured: 60, 90, 180-day post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jun 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia E Krantz, MBA, Study director, Cytrellis Biosystems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583918
- Sponsor's protocol ID
- Optimization of MCD treatment
- Other IDs
- AIS 700-00022
- Acronym
- MCD
- Status last verified
- Jul 2018
- First submitted
- 16 Aug 2017
- Last updated
- 12 Jul 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 12 Jul 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 Efficacy of Micro-Excisional Skin Remodeling With Micro-Coring Device in the Treatment of Wrinkles and Skin Laxity of Face and Neck
- ClinicalTrials.gov ID
- NCT03583918
- Acronym / sponsor ID
- MCD / Optimization of MCD treatment
- Conditions
- Laxity; Skin
- Keywords
- facial wrinkles, skin laxity, sagging skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 12 Jul 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.
This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.
Detailed description
The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent.
The subjects will be evaluated at each visit and following data will be collected:
- The incidence and severity of systemic and local adverse events.
- Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale.
- Changes in skin laxity assessed by Laxity Scale.
- Canfield Image Analyses.
- Needle and/or punch biopsy (in some subjects).
- Overall aesthetic improvement using the following scales:
- Subject and PI Global Aesthetic Improvement Scale (GAIS)
- Subject Satisfaction Scale
- Rhytides and Laxity Scale
- Lower face assessment
- Investigator evaluation of device usability and functionality. Data Analysis: Analyses will be conducted per measurement tools listed. Statistical analysis will include but will not be limited to T tests, univariate and multivariate analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Highthroughput Micro Coring Device | Experimental | Device: HighThroughput Micro Coring DeviceSkin excision and removal with with Highthroughput Micro Coring device |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fitzpatrick Skin Type 1, 2, or 3 as judged by the Investigator
- Two or more of the following: Facial wrinkles assessed using the Lemperle Wrinkle Assessment Scale (descriptive and pictorial)
- Able to provide written informed consent, understand and willing to comply with all study related directions from investigator and follow-up visits.
Key exclusion criteria (21 listed)
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone or synthetic material injections in the areas to be treated
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 |
|---|---|---|
| HighThroughput Micro Coring DeviceAlso: skin micro-coringAssess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device | Device | Highthroughput Micro Coring Device |
Primary outcome
Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale
Time frame: 90-day post-treatment
Assess wrinkle reduction in wrinkle severity score from the baseline assessed by Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale. No wrinkles = 0; Just perceptible wrinkles = 1; Shallow wrinkles = 2; Moderately deep wrinkles = 3; Deep wrinkles, well-defined edges = 4; Very deep wrinkles, redundant fold = 5
2 secondary outcomes
Assess skin laxity Improvement at 90 days post treatment
Time frame: 90-day post-treatment
Assess skin for new collagenases
Time frame: 60, 90, 180-day post treatment
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 12 Jul 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. This study is not recruiting at the moment.
Patricia E Krantz, MBA study director
Cytrellis Biosystems, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HighThroughput Micro Coring Device in people with Laxity; Skin, run by Cytrellis Biosystems, Inc. at 5 sites 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 10 inclusion and 21 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale (time frame: 90-day post-treatment). 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 12 Jul 2018.