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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Best Practices; Ellacor; Micro-coring Post Care; Ellacor Post Care
• Intervention / Treatment: Device: ellacor Micro-Coring Technology

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Institute
  • Kentucky
    • Louisville, Kentucky, United States, 42022
      • Caloaesthetics Plastic Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Informed Consent Form

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 clinically significant bleeding disorder

i. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.; Other Names: micro-coring; dermal micro-coring; ellacor
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; ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.; Other Names: micro-coring; dermal micro-coring; ellacor
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; ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.; Other Names: micro-coring; dermal micro-coring; ellacor
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; ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.; Other Names: micro-coring; dermal micro-coring; ellacor
Active Comparator: Tegaderm Only; Patient will only receive Tegaderm for post-care	Device: ellacor Micro-Coring Technology; ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.; Other Names: micro-coring; dermal micro-coring; ellacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Aesthetic Improvement Scale (GAIS)	Treatment improvement will be evaluated based off the 7 grade GAIS by both the subject and the physician.	GAIS Assessment will be performed under a timeframe of 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Clinical assessment will be performed at each follow up throughout the study period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0 to end of study period
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.	Day 90

Collaborators and Investigators

• Sponsor: Cytrellis Biosystems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ellacor post care; micro-coring best practices; ellacor best practices
• Other Study ID Numbers: TP-00456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No