An interventional study of HA-coated P(LA/CL) lifting threads and P(LA/CL) lifting threads without HA coating in Nasolabial Fold Correction and Midface, sponsored by Aptos, LLC.. Completed at 3 sites in Georgia. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Aptos, LLC. · Not applicable, Interventional, and Treatment
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
This is the only study on the registry with Aptos, LLC. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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) \[P(LA/CL)\] 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.
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.
Incidence of device and procedure related serious adverse events by Day 30 (Month 1) after the implantation procedure.
Time frame: From implantation through Day 30.
Reduction in nasolabial fold 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).
The five-point Wrinkle Severity Rating Scale (WSRS) assesses nasolabial fold (NLF) severity, with higher scores indicating greater severity. Grade 1 (absent) indicates a continuous skin line with no visible fold. Grade 2 (mild) indicates a shallow but visible fold with a slight indentation. Grade 3 (moderate) indicates a moderately deep fold visible at rest. Grade 4 (severe) indicates a very long, deep fold that is a prominent facial feature, with less than 2 mm of the fold remaining visible when the skin is stretched. Grade 5 (extreme) indicates an extremely deep, long fold that retains a 2-4 mm V-shaped indentation when the skin is stretched. Higher scores indicating greater wrinkle severity and more pronounced folds, while lower scores indicate reduced wrinkle severity and less pronounced folds.
Time frame: Baseline and Day 90 after implantation
Incidence of all adverse events after implantation of threads throughout the whole study.
Time frame: 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)
Time frame: Up to Day 14 after the implantation procedure.
Observed values and change from baseline in Wrinkle Severity Rating Scale (WSRS)
The five-point Wrinkle Severity Rating Scale (WSRS) was used to assess the severity of nasolabial folds, with scores ranging from 1 (absent) to 5 (extreme), where higher scores indicate greater wrinkle severity and lower scores indicate less pronounced folds. Changes in Wrinkle Severity Rating Scale from baseline were used to evaluate treatment outcomes. A decrease in score indicates an improvement in nasolabial fold severity, an increase in score indicates worsening severity. No change in score indicates that the severity of the nasolabial folds remained unchanged compared with baseline.
Time frame: On Day 30 and Day 180.
The proportion of subjects with improvement of ≥1 Wrinkle Severity Rating Scale (WSRS) score at each visit
Time frame: Days 30, 90, and 180 after implantation.
Mean Global Aesthetic Improvement Scale (GAIS) value assessed by blinded evaluators with frequency of each grade and sum of improved subjects.
Global Aesthetic Improvement Scale assessment for physicians five-point scale presented, where 1 - Very Much Improved, 2 - Much Improved, 3 - Improved, 4 \- No Change and 5 - worsened. Lower scores indicated greater aesthetic improvement, with a score of 1 representing the most favorable outcome and a score of 5 indicating the least favorable outcome.
Time frame: On Day 30, Day 90, and Day 180
Mean Global Aesthetic Improvement Scale (GAIS) value assessed by subject with frequency of each grade and sum of improved subjects
Global Aesthetic Improvement Scale assessment for subjects. five-point scale presented, where 1 - Very Much Improved, 2 - Much Improved, 3 - Improved, 4 \- No Change and 5 - worsened. Lower scores indicated greater aesthetic improvement, with a score of 1 representing the most favorable outcome and a score of 5 indicating the least favorable outcome.
Time frame: Days 30, 90, and 180 after implantation.
Patient satisfaction with the procedure outcome assessed using the mean total Face-QTM Satisfaction with Outcome score.
Participants indicate how strongly they agree or disagree with each of the following six statements about the procedure. 1. I am pleased with the result. 2. The result turned out great. 3. The result was just as I expected. 4. I am surprised at how good I look in the mirror. 5. The result is fantastic. 6. The result is miraculous. Each statement is scored from 1 to 4 (1 = definitely disagree, 2 = somewhat disagree, 3 = somewhat agree, 4 = definitely agree). The total score ranges from 6 (minimum) to 24 (maximum). Higher scores indicate greater satisfaction with the outcome, while lower scores indicate less satisfaction.
Time frame: At Day 30 (Month 1), Day 90 (Month 3), and Day 180 (Month 6) after the implantation procedure.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.