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

NCT07260578 | Enrolling By Invitation FDA Device

• 1 other identifier: TP-00456
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

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

Keywords

ellacor post care; micro-coring best practices; ellacor best practices

Outcome Measures

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.

  GAIS Assessment will be performed under a timeframe of 90 days

Secondary Outcomes (1)

• Clinical Assessment

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

Other Outcomes (2)

• Safety Outcomes

  Day 0 to end of study period

• Subject Satisfaction Survey

  Day 90

Study Arms (5)

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

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.

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

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

Device: ellacor Micro-Coring Technology

Tegaderm Only

ACTIVE COMPARATOR

Patient will only receive Tegaderm for post-care

Device: ellacor Micro-Coring Technology

Interventions

ellacor Micro-Coring Technology DEVICE

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

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

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (2)

Miami Dermatology And Laser Institute

Miami, Florida, 33173, United States

Location

Caloaesthetics Plastic Surgery Center

Louisville, Kentucky, 42022, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 3, 2025
• Study Start: November 26, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)