HA-Coated and Non-HA Threads for Midface Lifting and Nasolabial Fold Correction
NCT07916103, Not applicable, Completed, Aptos, LLC.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | HA-Coated and Non-HA Threads for Midface Lifting and Nasolabial Fold Correction | ClinicalTrials.gov |
| NCT number | NCT07916103 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 144 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Aptos, LLC. | ClinicalTrials.gov |
| Conditions | Nasolabial Fold Correction, Midface | ClinicalTrials.gov |
| Interventions | HA-coated P(LA/CL) lifting threads, P(LA/CL) lifting threads without HA coating | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of device and procedure related serious adverse events by Day 30 (Month 1) after the implantation procedure. | From implantation through Day 30. | ClinicalTrials.gov | |
| Primary | 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). | Baseline and Day 90 after implantation | 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. | ClinicalTrials.gov |
| Secondary | Incidence of all adverse events after implantation of threads throughout the whole study. | through Day 180 [Month 6] after the implantation procedure | ClinicalTrials.gov | |
| Secondary | 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. | ClinicalTrials.gov | |
| Secondary | Observed values and change from baseline in Wrinkle Severity Rating Scale (WSRS) | On Day 30 and Day 180. | 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. | ClinicalTrials.gov |
| Secondary | The proportion of subjects with improvement of ≥1 Wrinkle Severity Rating Scale (WSRS) score at each visit | Days 30, 90, and 180 after implantation. | ClinicalTrials.gov | |
| Secondary | Mean Global Aesthetic Improvement Scale (GAIS) value assessed by blinded evaluators with frequency of each grade and sum of improved subjects. | On Day 30, Day 90, and Day 180 | 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. | ClinicalTrials.gov |
| Secondary | Mean Global Aesthetic Improvement Scale (GAIS) value assessed by subject with frequency of each grade and sum of improved subjects | Days 30, 90, and 180 after implantation. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)