Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06993558
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Study Overview
Official Title:
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators.
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Biostimulation
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| University Hamburg Eppendorf | OTHER | Medicine Faculty - Clinic and Polyclinic for Dermatology and Venerology | View |