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Safety and Performance of PTMC Dermal Filler

Aqpha Medical B.V. · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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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.
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