HA-Coated and Non-HA Threads for Midface Lifting and Nasolabial Fold Correction

Evaluation of Safety and Effectiveness of APTOS Threads - Absorbable Surgical Sutures Excellence Product Line Models for Mid-face Suspension by Mini-Invasive Surgery to Temporarily Fixate the Cheek Sub-dermis in a Repositioned Site for the Treatment of Moderate to Severe Nasolabial Fold.

This randomized study compared absorbable facial lifting threads with and without a hyaluronic acid (HA) coating in 144 adults with moderate-to-severe nasolabial folds, the lines extending from the sides of the nose toward the corners of the mouth. Participants were randomly assigned in a 1:1 ratio to receive either HA-coated or non-HA threads.

Follow-up continued for six months. The main assessments evaluated adverse events through Day 30 and changes in nasolabial fold severity at Day 90. Independent evaluators assessed standardized photographs, and participants rated their aesthetic improvement and satisfaction. Additional assessments examined safety and maintenance of improvement through Day 180

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold Correction; Midface
• Intervention / Treatment: Device: HA-coated P(LA/CL) lifting threads; Device: P(LA/CL) lifting threads without HA coating

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Batumi, Georgia, 6000
    • "Total Charm Piazza",15 Vakhtang Gorgasali Street
  • Tbilisi, Georgia, 0109
    • "Total Charm LTD", Orbeliani Str #18
  • Tbilisi, Georgia, 0162
    • "Total Charm Vake", 87B Zakaria Paliashvili Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects, 22+ years of age.
2. Subjects who desire cheek lifting to correct age-related wrinkles in the mid-face as recommended by the treating investigator.
3. Subject received a rating, in each cheek, by Investigator of at least Grade 3 or Grade 4 for wrinkling of the NLF in the mid-face according to the WSRS.
4. If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must have a confirmed negative urine pregnancy test result at screening. If treatment is not provided at the screening visit, a negative urine pregnancy test result is required within 7 days before treatment.
5. If a woman of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), subject confirms she will utilize at least one form of contraception throughout the duration of the study (6 months).
6. Subjects who are able to understand the study requirements, including the obligation not to receive any other facial procedures or treatments affecting mid-face at any time during the study. These include procedures or treatments done at home or with a professional. Facial treatments include lasers, facial massages, and anything beyond common skincare routine.
7. Subjects who are willing to participate in the study and to sign a witnessed/informed consent form.
8. Subjects who are logistically able to present for all study visits and meet all study requirements.
9. Subjects who are willing to complete a 30-day diary.
10. Subjects who pass the pinprick and/or cotton swab facial nerve assessment

Exclusion Criteria:

1. Abnormal rating in mid-face sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the mid-face.
2. Active acne or prominent acne scars in the treatment area.
3. Active inflammatory or infectious conditions.
4. Allergy or foreign body sensitivities to plastic biomaterials.
5. Known bleeding disorder.
6. Breast feeding, pregnant, or not on/willing to use contraception if of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile).
7. Known collagen skin disorder.
8. Pre-existing facial asymmetry.
9. History of any device use on the mid-face in the prior 6 months (laser, Intense Pulsed Light [IPL], radiofrequency (RF), ultrasound, micro needling, micro needle RF, or cool based treatments).
10. History of autoimmune or connective tissue disease.
11. History of facelift, mid-face lift, lower facelift or neck lift that changes the facial structure and anchor points.
12. History of fat transfer to the mid-face.
13. History of injectable fillers other than temporary fillers such as HA or Radiesse to the mid-face at any time. Permanent and semi-permanent fillers are not allowed (Poly-L-lactic acids [PLLA], Sculptra).
14. History of Kybella in the prior 6 months.
15. History of facial trauma in the mid-face.
16. History of facial surgical procedures.
17. Inability to chew, puff cheek, or smile broadly.
18. Metabolism irregularities.
19. Receiving immunosuppressive therapy.
20. Recent weight loss or intention to lose a significant amount of weight during the study period (2 body mass index [BMI] points).
21. Subjects who have undergone cosmetic facial plastic surgery (with the exception of rhinoplasty or upper blepharoplasty) more than 2 years prior to enrollment, tissue grafting, or tissue lifting or augmentation with any permanent or semi-permanent filler.
22. Subjects who have had temporary facial dermal filler injections below the orbital rim with HA-based fillers or Radiesse within 18 months, porcine-based collagen fillers within 24 months, or neuromodulator injections to the mid-face or lateral canthal lines, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months of entry in the study or who were planning to undergo any of these procedures at any time during the study.
23. Subjects who have very thin skin in the mid-face region, who have a tendency to accumulate fluid in the lower eyelids, or who have large infraorbital fat pads (i.e., significant convexity or projection from the infraorbital fat pads).
24. Subjects who have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIVrelated disease.
25. Subjects who are included to list of vulnerable populations (pediatric, pregnant, elderly individuals with visual or hearing impairments, mentally ill subjects).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HA-Coated P(LA/CL) Lifting Threads; Participants received absorbable poly(L-lactide-co-ε-caprolactone) [P(LA/CL)] lifting threads coated with hyaluronic acid in a single bilateral midface procedure under local anesthesia. Five threads were placed subcutaneously on each side of the face. Visage Excellence HA, Visage Excellence Soft HA, or Nano Excellence HA threads were selected according to the planned implantation trajectory. Participants were followed for six months after implantation.	Device: HA-coated P(LA/CL) lifting threads; The device consists of absorbable, multibarbed monofilament threads made from poly(L-lactide-co-ε-caprolactone) [P(LA/CL)] and coated with non-animal-derived, non-cross-linked, medium-molecular-weight sodium hyaluronate. Manufactured by Aptos LLC, Georgia, the models used were Visage Excellence HA (190 mm), Visage Excellence Soft HA (100 mm), and Nano Excellence HA (80 mm). All models had the same number of barbs despite their different lengths and were supplied preloaded in cannulas for subcutaneous tissue repositioning.
Experimental: Non-HA-Coated P(LA/CL) Lifting Threads; Participants received absorbable poly(L-lactide-co-ε-caprolactone) [P(LA/CL)] lifting threads without hyaluronic acid coating in a single bilateral midface procedure under local anesthesia. Five threads were placed subcutaneously on each side of the face. Visage Excellence, Visage Excellence Soft, or Nano Excellence threads were selected according to the planned implantation trajectory. Participants were followed for six months after implantation.	Device: P(LA/CL) lifting threads without HA coating; The device consists of absorbable, multibarbed monofilament threads made from poly(L-lactide-co-ε-caprolactone) [P(LA/CL)] without hyaluronic acid coating. Manufactured by Aptos LLC, Georgia, the models used were Visage Excellence (190 mm), Visage Excellence Soft (100 mm), and Nano Excellence (80 mm). All models had the same number of barbs despite their different lengths and were supplied preloaded in cannulas for subcutaneous tissue repositioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of device and procedure related serious adverse events by Day 30 (Month 1) after the implantation procedure.	From implantation through Day 30.
Reduction in NLF severity at Day 90 (Month 3) after the implantation procedure in comparison with baseline grading, as assessed by blinded evaluators using the Wrinkles Severity Rating Scale (WSRS).	Baseline and Day 90 after implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of all adverse events after implantation of threads throughout the whole study.	through Day 180 [Month 6] after the implantation procedure
Incidence of early recovery symptoms related to the treatment (threads implantation) among adverse events reported by both patients and treating physician(s)	Up to Day 14 after the implantation procedure.
Observed values and change from baseline in WSRS	On Day 30 and Day 180.
The proportion of subjects with improvement of ≥1 WSRS score at each visit	Days 30, 90, and 180 after implantation.
Mean GAIS value assessed by blinded evaluators with frequency of each grade and sum of improved subjects (excellent, very much improved, improved)	On Day 30, Day 90, and Day 180
Mean GAIS value assessed by subject with frequency of each grade and sum of improved subjects (excellent, very much improved, improved)	Days 30, 90, and 180 after implantation.
Patient satisfaction with the procedure outcome assessed using the mean total Face-QTM Satisfaction with Outcome score.	At Day 30 (Month 1), Day 90 (Month 3), and Day 180 (Month 6) after the implantation procedure.

Collaborators and Investigators

• Sponsor: Aptos, LLC.
• Collaborators: Clinical Accelerator
• Investigators: Study Chair: Anna Kadzhaya, MD, Aptos LLC, Tbilisi, Georgia.15 Givi Amilakhvari Street

Publications and helpful links

General Publications

• Niu Z, Zhang K, Yao W, Li Y, Jiang W, Zhang Q, Troulis MJ, August M, Chen Y, Han Y. A Meta-Analysis and Systematic Review of the Incidences of Complications Following Facial Thread-Lifting. Aesthetic Plast Surg. 2021 Oct;45(5):2148-2158. doi: 10.1007/s00266-021-02256-w. Epub 2021 Apr 5.
• Day DJ, Littler CM, Swift RW, Gottlieb S. The wrinkle severity rating scale: a validation study. Am J Clin Dermatol. 2004;5(1):49-52. doi: 10.2165/00128071-200405010-00007.
• Ziade G, Daou D, Karam D, Tsintsadze M. The third generation barbed lifting threads: Added value of hyaluronic acid. J Cosmet Dermatol. 2024 Jan;23(1):186-192. doi: 10.1111/jocd.15885. Epub 2023 Jul 19.
• Wong V. The Science of Absorbable Poly(L-Lactide-Co-epsilon-Caprolactone) Threads for Soft Tissue Repositioning of the Face: An Evidence-Based Evaluation of Their Physical Properties and Clinical Application. Clin Cosmet Investig Dermatol. 2021 Jan 13;14:45-54. doi: 10.2147/CCID.S274160. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Thread lifting; nasolabial folds; hyaluronic acid; facial rejuvenation; Aptos threads; P(LA/CL) threads.
• Other Study ID Numbers: Excellence - 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No