Safety and Efficacy of Ellacor® Micro-coring® Following Best Practices on Technique and Post-Procedural Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ellacor Micro-Coring Technology.
- Who it may be relevant to
- Registry conditions: Best Practices, Ellacor, Micro-coring Post Care, Ellacor Post Care. Basic parameters: 45 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of Ellacor Micro-coring Following Best Practices on Technique and Post-Procedural Care
Overview
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
Interventions
- 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.
Primary outcome measures
- Global Aesthetic Improvement Scale (GAIS) [Time frame: GAIS Assessment will be performed under a timeframe of 90 days]
Secondary outcome measures (1)
- Clinical Assessment [Time frame: Clinical assessment will be performed at each follow up throughout the study period.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Miami Dermatology And Laser Institute — Miami
- Caloaesthetics Plastic Surgery Center — Louisville
Identifiers
NCT: NCT07260578 · TP-00456