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

NCT ID: NCT07260578

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Best Practices Ellacor Micro-coring Post Care Ellacor Post Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

ellacor Micro-Coring Technology

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

ellacor Micro-Coring Technology

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

ellacor Micro-Coring Technology

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

ellacor Micro-Coring Technology

Intervention Type DEVICE

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

Tegaderm Only

Patient will only receive Tegaderm for post-care

Group Type ACTIVE_COMPARATOR

ellacor Micro-Coring Technology

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ellacor micro-coring dermal micro-coring

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cytrellis Biosystems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Miami Dermatology And Laser Institute

Miami, Florida, United States

Site Status RECRUITING

Caloaesthetics Plastic Surgery Center

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karyn VP of Clinical and Medical Affairs, PhD

Role: CONTACT

949-394-0585

Delia Medical Science Liaison, PharmD

Role: CONTACT

305-484-4948

Facility Contacts

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Biankah Hinkle

Role: primary

(305) 279-6060

Dawn Study Coordinator

Role: primary

(859) 459-0658

Other Identifiers

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TP-00456

Identifier Type: -

Identifier Source: org_study_id

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