Best PracticesNCT07260578
Safety and Efficacy of Ellacor® Micro-coring® Following Best Practices on Technique and Post-Procedural Care
A study testing ellacor Micro-Coring Technology in people with Best Practices and Ellacor, run by Cytrellis Biosystems, Inc. at 2 sites in United States.
Trial summary
Since its inception of being marketed in the United States in 2021, physicians have used various post procedure skin care regimen to facilitate recovery. This study aims to examine the use of three post care products in five skin care regimens Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Best Practices, Ellacor, Micro-coring Post Care
- What is being tested?
- ellacor Micro-Coring Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2025to Jun 2026
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adult, between the ages of 45 and 65
- Fitzpatrick Skin Type I to IV
- Have moderate to severe wrinkles on the mid and lower face, according to Lemperle Wrinkle Severity Scale (LWSS), i.e. score 3, 4 or 5.
- Willingness to sign Informed Consent Form
Who cannot join
- Pregnant women or nursing mothers
- Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
- Patients with allergy to stainless steel or to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
- Patients with a history or presence of any clinically significant bleeding disorder
- Patients with dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus e. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection) f. Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days g. Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area h. Patients have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old i. Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months j. Patients with scars less than six (6) months old in the treatment area k. During the study time frame, unwilling to refrain from receiving these following aesthetic treatments: toxin, filler, any skin resurfacing (laser, RF, ultrasound, microneedling, etc.); l. Have enrolled in another clinical trial during or overlapping part of this study m. Unwilling to have facial photography taken for the study purpose n. Any physical or psychological factors, in the judgment of the study investigator, may prevent subject from performing the procedure correctly.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Caloaesthetics Plastic Surgery Center
Louisville, Kentucky, 42022
Miami Dermatology And Laser Institute
Miami, Florida, 33173
About this study
Official title: Safety and Efficacy of Ellacor Micro-coring Following Best Practices on Technique and Post-Procedural Care
Since its inception of being marketed in the United States in 2021, physicians have used various post procedure skin care regimen to facilitate recovery. This study aims to examine the use of three post care products in five skin care regimens
- Conditions
- Best Practices, Ellacor, Micro-coring Post Care, Ellacor Post Care
- Being tested
- ellacor Micro-Coring Technology
- Keywords
- ellacor post care, micro-coring best practices, ellacor best practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ellacor Micro-Coring TechnologyDevice
Also called ellacor, micro-coring, dermal micro-coring
ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.
| Study group | Role | What they receive |
|---|---|---|
| Regenerating Skin Nectar (by Alastin) + Tegaderm | Active comparator | Alastin to be applied post procedure followed up Tegaderm. Tegaderm will be left on for 12 hours. Alastin will be applied twice daily for the duration of the study Receives: Device: ellacor Micro-Coring Technology |
| Kerra+ Recovery Cream (by Quthero) + Tegaderm | Active comparator | Patients will receive Kerra+ post procedure followed by Tegaderm. The Tegaderm is removed after 12 hours. Kerra+ will be applied twice daily for the duration of the study. Receives: Device: ellacor Micro-Coring Technology |
| Ariessence Platelet-Derived Growth Factor (PDGF) solution +Alastin + Tegaderm | Active comparator | Patients will receive PDGF immediately post procedure followed by Alastin followed by Tegaderm. The Tegaderm will be removed after 12 hours and the Alastin will continue to be applied twice daily for the duration of the study Receives: Device: ellacor Micro-Coring Technology |
| Ariessence PDGF solution + Kerra+ Recovery Cream + Tegaderm | Active comparator | Patients will receive PDGF immediately post procedure followed by Kerra+ followed by Tegaderm. The Tegaderm will be removed after 12 hours and the Kerra+ will continue to be applied twice daily for the duration of the study Receives: Device: ellacor Micro-Coring Technology |
| Tegaderm Only | Active comparator | Patient will only receive Tegaderm for post-care Receives: Device: ellacor Micro-Coring Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale (GAIS)
Treatment improvement will be evaluated based off the 7 grade GAIS by both the subject and the physician.
Measured: GAIS Assessment will be performed under a timeframe of 90 days
Secondary outcomes (1)
Clinical Assessment
Clinical assessment will be performed, and graded on a 0-3 scale on Day 0, Day 7, Day 30, and Day 90- 0 = absent, 1 = mild, 2 = moderate, 3 = severe for the following side effects:
- Bleeding
- Erythema - redness
- Ecchymosis - bruising
- Dryness, roughness
- Crusting Tenderness
- Numbness
- Edema - swelling
- Burning
- Tightness/Pulling of Skin
- Pain/Discomfort
- Tingling
- Skin Peeling
- Circular Marks on skin
- Any other observation
Measured: Clinical assessment will be performed at each follow up throughout the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start26 Nov 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Best PracticesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT07260578
- Sponsor's protocol ID
- TP-00456
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ellacor Micro-coring Following Best Practices on Technique and Post-Procedural Care
- ClinicalTrials.gov ID
- NCT07260578
- Acronym / sponsor ID
- TP-00456
- Conditions
- Best Practices, Ellacor, Micro-coring Post Care, Ellacor Post Care
- Keywords
- ellacor post care, micro-coring best practices, ellacor best practices
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
Since its inception of being marketed in the United States in 2021, physicians have used various post procedure skin care regimen to facilitate recovery. This study aims to examine the use of three post care products in five skin care regimens
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Regenerating Skin Nectar (by Alastin) + Tegaderm | Active comparator | Device: ellacor Micro-Coring TechnologyAlastin to be applied post procedure followed up Tegaderm. Tegaderm will be left on for 12 hours. Alastin will be applied twice daily for the duration of the study |
| Kerra+ Recovery Cream (by Quthero) + Tegaderm | Active comparator | Device: ellacor Micro-Coring TechnologyPatients will receive Kerra+ post procedure followed by Tegaderm. The Tegaderm is removed after 12 hours. Kerra+ will be applied twice daily for the duration of the study. |
| Ariessence Platelet-Derived Growth Factor (PDGF) solution +Alastin + Tegaderm | Active comparator | Device: ellacor Micro-Coring TechnologyPatients will receive PDGF immediately post procedure followed by Alastin followed by Tegaderm. The Tegaderm will be removed after 12 hours and the Alastin will continue to be applied twice daily for the duration of the study |
| Ariessence PDGF solution + Kerra+ Recovery Cream + Tegaderm | Active comparator | Device: ellacor Micro-Coring TechnologyPatients will receive PDGF immediately post procedure followed by Kerra+ followed by Tegaderm. The Tegaderm will be removed after 12 hours and the Kerra+ will continue to be applied twice daily for the duration of the study |
| Tegaderm Only | Active comparator | Device: ellacor Micro-Coring TechnologyPatient will only receive Tegaderm for post-care |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female adult, between the ages of 45 and 65
- Fitzpatrick Skin Type I to IV
- Have moderate to severe wrinkles on the mid and lower face, according to Lemperle Wrinkle Severity Scale (LWSS), i.e. score 3, 4 or 5.
- Willingness to sign Informed Consent Form
Key exclusion criteria (5 listed)
- Pregnant women or nursing mothers
- Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
- Patients with allergy to stainless steel or to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
- Patients with a history or presence of any clinically significant bleeding disorder
- Patients with dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus e. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection) f. Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days g. Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area h. Patients have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old i. Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months j. Patients with scars less than six (6) months old in the treatment area k. During the study time frame, unwilling to refrain from receiving these following aesthetic treatments: toxin, filler, any skin resurfacing (laser, RF, ultrasound, microneedling, etc.); l. Have enrolled in another clinical trial during or overlapping part of this study m. Unwilling to have facial photography taken for the study purpose n. Any physical or psychological factors, in the judgment of the study investigator, may prevent subject from performing the procedure correctly.
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 TechnologyAlso: ellacor, micro-coring, dermal micro-coringellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65. | Device | Ariessence PDGF solution + Kerra+ Recovery Cream + Tegaderm, Ariessence Platelet-Derived Growth Factor (PDGF) solution +Alastin + Tegaderm, Kerra+ Recovery Cream (by Quthero) + Tegaderm, Regenerating Skin Nectar (by Alastin) + Tegaderm, Tegaderm Only |
Primary outcome
Global Aesthetic Improvement Scale (GAIS)
Time frame: GAIS Assessment will be performed under a timeframe of 90 days
Treatment improvement will be evaluated based off the 7 grade GAIS by both the subject and the physician.
1 secondary outcome
Clinical Assessment
Time frame: Clinical assessment will be performed at each follow up throughout the study period.
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 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Best Practices
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Exploring The Effect of TikTok Trigger Warnings in a Clinical Sample of Youth at Risk of Suicide
Suicide Prevention, Social Media Users
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
EXtubation Related Complications - the EXTUBE Study (EXTUBE)
Extubation
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Technology in people with Best Practices and Ellacor, run by Cytrellis Biosystems, Inc. at 2 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 5 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: enrolling by invitation, as of the sponsor's last update on 16 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 2 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?
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?
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?
Global Aesthetic Improvement Scale (GAIS) (time frame: GAIS Assessment will be performed under a timeframe of 90 days). 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 Mar 2026.