Status:
RECRUITING
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers
Eligibility:
All Genders
30+ years
Phase:
NA
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) bi...
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, ...
Eligibility Criteria
Inclusion
- Men and women aged 30 years and older
- Good general health, no relevant pre-existing conditions
- Patients planning to undergo CaHa, PLLA, or RFMN treatment as part of routine care due to skin laxity or volume loss
- Cognitive ability and willingness to provide informed consent
- Willingness and ability to attend follow-up visits
Exclusion
- Age under 30 years
- Pregnant or breastfeeding individuals
- Significant open wounds or lesions in the treatment area
- Metallic implants in the treatment area
- Psychiatric disorders (psychosis, body dysmorphic disorders)
- Missing informed consent and/or data privacy declarations
Key Trial Info
Start Date :
March 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 22 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06993558
Start Date
March 22 2025
End Date
September 22 2026
Last Update
May 29 2025
Active Locations (1)
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1
University Hospital Hamburg Eppendorf
Hamburg, Hamburg, Germany, 20246