Micro-Coring® for the Treatment of Skin Laxity of the Knees

NCT07409090 | Enrolling By Invitation FDA Device

• 1 other identifier: TP-00460
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Body; Knees

Keywords

Micro-Coring; Body Coring; ellacor

Outcome Measures

Primary Outcomes (1)

• Correct identification of before and after treatment photos

  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.

  90 days

Study Arms (1)

Micro-Coring on the knees

OTHER

ellacor as the micro-coring intervention

Device: Micro-Coring

Interventions

Micro-Coring DEVICE

Non-thermal device

Also known as: ellacor

Micro-Coring on the knees

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (1)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 13, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

US (1)