Laxity; SkinNCT03573271
Pivotal Study to Evaluate the Safety and Efficacy of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
A study testing MCD in people with Laxity; Skin, run by Cytrellis Biosystems, Inc. at 5 sites in United States.
Trial summary
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- 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
- 5 sitesUnited States
- Study dates
- 26 Mar 2018to 28 Feb 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator.
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures 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 injections in the areas to be treated
- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
Show all 16Show fewer
- 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
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
- Female and pregnant or plan on becoming pregnant during the study
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, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Read the detailed description
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.
Evaluation results will be based in the following:
- Wrinkle severity score assessed using the Lemperle Wrinkle Scale
- Subject Satisfaction Scale
- PI Global Aesthetic Improvement Scale
- Conditions
- Laxity; Skin
- Being tested
- MCD
- 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.
MCDDevice
Micro-coring skin removal with automated coring device
| Study group | Role | What they receive |
|---|---|---|
| Micro-coring of facial/neck skin with MCD | Experimental | Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post 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 wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale
Measured: 90 day post treatment
Secondary outcomes (1)
Assess safety profile by recording of adverse events
Adverse events will be recorded throughout the study
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start26 Mar 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Krantz, Study director, Cytrellis Biosystems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573271
- Sponsor's protocol ID
- AIS 700-00041
- Status last verified
- Mar 2021
- First submitted
- 14 Jun 2018
- Last updated
- 9 Apr 2026
- 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
- ClinicalTrials.gov ID
- NCT03573271
- Acronym / sponsor ID
- AIS 700-00041
- Conditions
- Laxity; Skin
- Keywords
- facial wrinkles, skin laxity, sagging skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 Jun 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.
Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Detailed description
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.
Evaluation results will be based in the following:
- Wrinkle severity score assessed using the Lemperle Wrinkle Scale
- Subject Satisfaction Scale
- PI Global Aesthetic Improvement 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 facial/neck skin with MCD | Experimental | Device: MCDMicro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator.
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits
Key exclusion criteria (16 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 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 |
|---|---|---|
| MCDMicro-coring skin removal with automated coring device | Device | Micro-coring of facial/neck skin with MCD |
Primary outcome
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
Time frame: 90 day post treatment
Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale
1 secondary outcome
Assess safety profile by recording of adverse events
Time frame: 90 days
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 9 Apr 2026.
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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 Krantz 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 MCD 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 4 inclusion and 16 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 9 Apr 2026. 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 level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment (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 9 Apr 2026.