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Safety and Performance of PTMC Dermal Filler

NCT06316479 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-18

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women.

The main questions it aims to answer are:

* Does the PTMC dermal filler maintain its performance for a minimum of 6 months?
* Is the treatment considered safe for participants?

Participants will:

* Before treatment, the investigator will assess your medical history, medication usage, and satisfaction with your wrinkles/folds.
* You'll receive one injection of the PTMC Dermal filler during your initial visit.
* For 30 days post-injection, you'll keep a diary to note any reactions like pain, redness, or swelling at the injection site.
* At the 1-month follow-up, you can request a 'touch-up' of the filler, extending your participation in the study.
* Participants will visit the clinic a total of 8 times, including the initial treatment and 7 follow-up visits, spanning up to 18 months.
* Each visit will last approximately 60-90 minutes. The visits will be conducted in person.

Conditions

  • Moderate to Severe Nasolabial Fold

Interventions

DEVICE

PTMC Dermal Filler

A total of 120 subjects will receive treatment with PTMC Dermal Filler. The volume of filler injected will vary depending on the severity of the nasolabial fold. Injections will be administered by the investigator at the beginning of the study, with the injection technique, plane, and volume recorded. Touch-up treatments are permitted at the 1-month follow-up visit, if necessary.

Sponsors & Collaborators

  • Aqpha Medical B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2024-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06316479 on ClinicalTrials.gov