WrinkleNCT03228641
Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity
A study testing micro-excisional skin removal with coring needle in people with Wrinkle and Facial and Neck Skin Laxity, run by Cytrellis Biosystems, Inc. at 6 sites in United States.
Trial summary
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Facial and Neck Skin Laxity
- What is being tested?
- micro-excisional skin removal with coring needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jun 2016to 31 Aug 2017
- 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 assessed by Investigator
- One or more of the following conditions assessed by Investigator using provided Severity Scales:
- Nasolabial fold severity at rest ≥2 and ≤4;
- Marionette line prominence at rest ≥2 and ≤4;
- Oral commissure drooping at rest ≥2 and ≤4;
- Jawline sagging at rest ≥2 and ≤4 .
- Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.
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
Show all 21Show fewer
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, 75231
Miami Dermatology and Laser Institute
Miami, Florida, 33173
Nashville Center for Laser & Facial Surgery
Nashville, Tennessee, 37203
Laser & Skin Surgery Center of NY
New York, New York, 10016
Laser & Skin Center of Northern CA
Sacramento, California, 95816
About this study
Official title: A Prospective, Multi-center, Randomized Pilot Study for the Safety and Efficacy of a GEN II Micro-coring Device for the Treatment of Wrinkles and Skin Laxity in the Pre-auricular Area and Mid to Lower Face
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).
Read the detailed description
This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest; prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of the skin at the jawline at rest. Subjects are blinded to needle gauge and density.
There will be two cohorts of subjects: one group of subjects will receive a single treatment and the second - multiple treatments. All subjects will be followed for 180 days with several intermediate visits at 3, 7, 30, 60, and 90-days.
- Conditions
- Wrinkle, Facial and Neck Skin Laxity
- Being tested
- micro-excisional skin removal with coring needle
- Keywords
- skin rejuvenation, wrinkle removal, skin laxity reduction
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-excisional skin removal with coring needleDevice
Also called micro-coring, micro-excisional skin removal
| Study group | Role | What they receive |
|---|---|---|
| micro-excisional skin removal | Experimental | Facial and neck wrinkles will be treated with micro-excisional skin removal Receives: Device: micro-excisional skin removal with coring needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in wrinkle appearance
One grade or better improvement in score on Wrinkle Severity Scale
Measured: 60 and 90 days
Secondary outcomes (1)
improvement in skin laxity
One grade or better improvement in score on Laxity Scale
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Jun 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michail M Pankratov, MD, PhD, Study director, Senior Vice President of Clinical & Regulatory AffairsPatricia E Krantz, Study director, Director of Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228641
- Sponsor's protocol ID
- 700-00001
- Status last verified
- Jun 2018
- First submitted
- 14 Feb 2017
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Clinical data analysis will be summarized in the Clinical Study Report and later submitted for publication in the peer-reviewed journal
Publications
Fernandes JR, Samayoa JC, Broelsch GF, McCormack MC, Nicholls AM, Randolph MA, Mihm MC, Austen WG Jr. Micro-mechanical fractional skin rejuvenation. Plast Reconstr Surg. 2013 Feb;131(2):216-223. doi: 10.1097/PRS.0b013e3182789afa.
PubMed 23357983Russe E, Purschke M, Farinelli WA, Wang Y, Doukas AG, Limpiangkanan W, Sakamoto FH, Tam J, Wechselberger G, Anderson RR. Micro-fractional, directional skin tightening: A porcine model. Lasers Surg Med. 2016 Mar;48(3):264-9. doi: 10.1002/lsm.22444. Epub 2015 Dec 2.
PubMed 26627306
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Pilot Study for the Safety and Efficacy of a GEN II Micro-coring Device for the Treatment of Wrinkles and Skin Laxity in the Pre-auricular Area and Mid to Lower Face
- ClinicalTrials.gov ID
- NCT03228641
- Acronym / sponsor ID
- 700-00001
- Conditions
- Wrinkle, Facial and Neck Skin Laxity
- Keywords
- skin rejuvenation, wrinkle removal, skin laxity reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 25 Jul 2017 (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 pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).
Detailed description
This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest; prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of the skin at the jawline at rest. Subjects are blinded to needle gauge and density.
There will be two cohorts of subjects: one group of subjects will receive a single treatment and the second - multiple treatments. All subjects will be followed for 180 days with several intermediate visits at 3, 7, 30, 60, and 90-days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro-excisional skin removal | Experimental | Device: micro-excisional skin removal with coring needleFacial and neck wrinkles will be treated with micro-excisional skin removal |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator
- One or more of the following conditions assessed by Investigator using provided Severity Scales:
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 |
|---|---|---|
| micro-excisional skin removal with coring needleAlso: micro-coring, micro-excisional skin removal | Device | micro-excisional skin removal |
Primary outcome
improvement in wrinkle appearance
Time frame: 60 and 90 days
One grade or better improvement in score on Wrinkle Severity Scale
1 secondary outcome
improvement in skin laxity
Time frame: up to 180 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 25 Mar 2026.
- Results publication: PubMed 23357983Fernandes JR, Samayoa JC, Broelsch GF, McCormack MC, Nicholls AM, Randolph MA, Mihm MC, Austen WG Jr. Micro-mechanical fractional skin rejuvenation. Plast Reconstr Surg. 2013 Feb;131(2):216-223. doi: 10.1097/PRS.0b013e3182789afa.
- Results publication: PubMed 26627306Russe E, Purschke M, Farinelli WA, Wang Y, Doukas AG, Limpiangkanan W, Sakamoto FH, Tam J, Wechselberger G, Anderson RR. Micro-fractional, directional skin tightening: A porcine model. Lasers Surg Med. 2016 Mar;48(3):264-9. doi: 10.1002/lsm.22444. Epub 2015 Dec 2.
- Individual participant dataSharing planned: No. Clinical data analysis will be summarized in the Clinical Study Report and later submitted for publication in the peer-reviewed journal
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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.
Michail M Pankratov, MD, PhD study director
Senior Vice President of Clinical & Regulatory Affairs
Patricia E Krantz study director
Director of Clinical Operations
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-excisional skin removal with coring needle in people with Wrinkle and Facial and Neck Skin Laxity, run by Cytrellis Biosystems, Inc. at 6 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 7 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
improvement in wrinkle appearance (time frame: 60 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228641, which also lists 2 linked publications.
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 25 Mar 2026.