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

Cytrellis

Status: Enrolling

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

Treatments: Device: ellacor Micro-Coring Technology

Study type: Interventional

Funder types: Industry

Identifiers

NCT07260578

TP-00456

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 5 patient groups

Regenerating Skin Nectar (by Alastin) + Tegaderm

Active Comparator group

Description:

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

Treatment:

Device: ellacor Micro-Coring Technology

Kerra+ Recovery Cream (by Quthero) + Tegaderm

Active Comparator group

Description:

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.

Treatment:

Device: ellacor Micro-Coring Technology

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

Active Comparator group

Description:

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

Treatment:

Device: ellacor Micro-Coring Technology

Ariessence PDGF solution + Kerra+ Recovery Cream + Tegaderm

Active Comparator group

Description:

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

Treatment:

Device: ellacor Micro-Coring Technology

Tegaderm Only

Active Comparator group

Description:

Patient will only receive Tegaderm for post-care

Treatment:

Device: ellacor Micro-Coring Technology