ClinicalTrials.gg
Enrolling by invitationNCT07260578Updated Mar 16, 2026

Safety and Efficacy of Ellacor® Micro-coring® Following Best Practices on Technique and Post-Procedural Care

An interventional study of ellacor Micro-Coring Technology in Best Practices, Ellacor and Micro-coring Post Care, sponsored by Cytrellis Biosystems, Inc.. Enrolling by invitation at 2 sites in United States. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Cytrellis Biosystems, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Best Practices
  • Ellacor
  • Micro-coring Post Care
  • Ellacor Post Care

Keywords

  • ellacor post care
  • micro-coring best practices
  • ellacor best practices
03

In context

Lead sponsor

Cytrellis Biosystems, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female adult, between the ages of 45 and 65
  2. Fitzpatrick Skin Type I to IV
  3. 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.
  4. Willingness to sign Form

Exclusion criteria

Exclusion Criteria:

  1. Pregnant women or nursing mothers
  2. Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
  3. 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
  4. Patients with a history or presence of any bleeding disorder

i. Patients with dermatological or 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 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 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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Regenerating Skin Nectar (by Alastin) + Tegaderm

    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

    Device: ellacor Micro-Coring Technology

  • Active comparator
    Kerra+ Recovery Cream (by Quthero) + Tegaderm

    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.

    Device: ellacor Micro-Coring Technology

  • Active comparator
    Ariessence Platelet-Derived Growth Factor (PDGF) solution +Alastin + Tegaderm

    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

    Device: ellacor Micro-Coring Technology

  • Active comparator
    Ariessence PDGF solution + Kerra+ Recovery Cream + Tegaderm

    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

    Device: ellacor Micro-Coring Technology

  • Active comparator
    Tegaderm Only

    Patient will only receive Tegaderm for post-care

    Device: ellacor Micro-Coring Technology

Interventions

  • Deviceellacor Micro-Coring Technology

    ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.

    Also known as: ellacor, micro-coring, dermal micro-coring

06

What researchers measure

Primary outcomes

  1. Global Aesthetic Improvement Scale (GAIS)

    Treatment improvement will be evaluated based off the 7 grade GAIS by both the subject and the physician.

    Time frame: 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

    Time frame: Clinical assessment will be performed at each follow up throughout the study period.

Other outcomes

  1. Safety Outcomes

    Safety will be evaluated throughout the duration of the study by recording adverse events on Day 0, Day 7, Day 30, and Day 90

    Time frame: Day 0 to end of study period

  2. Subject Satisfaction Survey

    Subject satisfaction data will be collected via a written questionnaire at the 90-day post procedure final follow-up visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied nor satisfied; 4) somewhat satisfied; 5) very satisfied.

    Time frame: Day 90

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for May 2026, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Dec 3, 2025
StartActual
Nov 26, 2025
Primary completionEst.
May 2026
CompletionEst.
Jun 2026
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07260578
Lead sponsor
Cytrellis Biosystems, Inc.
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Nov 26, 2025
Primary completion
May 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Mar 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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