Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06993558
Brief Summary:
The goal of this clinical trial is to analyse tissue changes in the pre-auricular region after injectable (Poly-L-Lactic-Acid/Calcium-Hydroxylapatit/ and energy-based (Radiofrequency Microneedling) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are:
How is the Safety Profile of Biostimulatory Treatments? How are the Tissue Interactions after Biostiomulatory Treatments?
Participants will:
* Recieve one of 3 possible biostumulatory treatments (PLLA/CAHA/RFM)
* Attend 5 follow-up appointments after treatment for checkups, surveillance and examinations.
Detailed Description:
Patients undergoing biostimulatory treatments will be invited to participate in this study involving photographic evaluations and ultrasound imaging. Following detailed oral and written explanations, patients will provide informed consent.
Participants will be assigned to one of three treatment groups:
1. PLLA (Sculptra®, Sinclair Pharmaceuticals)
2. CaHA (Radiesse®, Merz Pharma; HarmonyCa®, Allergan)
3. RFMN (Genius®, Lutronic Medical Systems)
Treatment Protocols:
* PLLA: 1-3 sessions at intervals of 4-6 weeks
* CaHA: Single session
* RFMN: 1-3 sessions at intervals of 6-8 weeks
These interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.
Follow-Up Assessments
Patients will undergo follow-up evaluations at 5 defined time points after treatment:
1. 6 weeks
2. 6 months
3. 12 months 4.18 months
5\. 24 months
Study:
NCT06993558
Study Brief:
Protocol Section:
NCT06993558