Body, Knees
Conditions
Keywords
Micro-Coring, Body Coring, ellacor
Brief summary
Early, informal clinical experience suggests that Micro-Coring may help improve skin quality in certain body areas, such as the knees. However, this body region has not yet been formally studied. Additional clinical evaluation is needed to better understand healing, potential side effects, patient experience, ease of use, and optimal treatment settings for body sites. This is especially important because body skin differs from facial skin in thickness, blood supply, movement, and mechanical stress, which may affect both safety and healing outcomes.
Interventions
DEVICEMicro-Coring
Non-thermal device
Sponsors
Cytrellis Biosystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female age 22 to 70 * With lax skin over one or both knees, physician discretion * Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits * Fitzpatrick Skin Type I to VI as evaluated by the Investigator
Exclusion criteria
* Pregnant women or nursing mothers * Body mass index \> 30 · 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 * 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 * Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection) * Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin \> 150 mg/day, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days * Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area * Patients with have undergone surgery of the treatment area within last twelve (12) months, or have any scars less than twelve (12) months old in the treatment area * 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 * During the study time frame, unwilling to refrain from receiving these following aesthetic treatments within the same body region: toxin, filler, any skin resurfacing (laser, RF, ultrasound, microneedling, etc.); * Are currently enrolled in, or have overlapping participation in, another clinical trial outside of Cytrellis that includes treatment to the study area. * Unwilling to have photography taken for the study purpose * Any physical or psychological factors, in the judgment of the study investigator, may prevent subject from adhering to the study requirement correctly. * History of keloid formation or hypertrophic scarring * Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment and for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct identification of before and after treatment photos | 90 days | The baseline photos (before) taken before the procedure, and 90-day post procedure visit photos (after) are randomized and presented to a panel of three blinded photographic evaluators. Study success is defined as 75% subjects or more show an improvement as agreed upon by a least two out of three evaluators. |
Countries
United States
Outcome results
None listed