Best Practices, Ellacor, Ellacor Post Care, Micro-coring Post Care
Conditions
Keywords
ellacor post care, micro-coring best practices, ellacor best practices
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
Interventions
DEVICEellacor Micro-Coring Technology
ellacor will be used to treat moderate-severe wrinkles in the mid to lower face in subjects aged between 45-65.
Sponsors
Cytrellis Biosystems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) | GAIS Assessment will be performed under a timeframe of 90 days | Treatment improvement will be evaluated based off the 7 grade GAIS by both the subject and the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment | Clinical assessment will be performed at each follow up throughout the study period. | Clinical assessment will be performed, and graded on a 0-3 scale on Day 0, Day 7, Day 30, and Day 90- 0 = absent, 1 = mild, 2 = moderate, 3 = severe for the following side effects: * Bleeding * Erythema - redness * Ecchymosis - bruising * Dryness, roughness * Crusting Tenderness * Numbness * Edema - swelling * Burning * Tightness/Pulling of Skin * Pain/Discomfort * Tingling * Skin Peeling * Circular Marks on skin * Any other observation |
Countries
United States
Outcome results
None listed