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
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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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-12-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
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
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.
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.
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.
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
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.
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
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.
Tegaderm Only
Patient will only receive Tegaderm for post-care
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
65 Years
ALL
Yes
Sponsors
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Cytrellis Biosystems, Inc.
INDUSTRY
Responsible Party
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Locations
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Miami Dermatology And Laser Institute
Miami, Florida, United States
Caloaesthetics Plastic Surgery Center
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TP-00456
Identifier Type: -
Identifier Source: org_study_id
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