Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effects of different biostimulatory treatments for the face, including injections and energy-based therapies, in healthy volunteers. The researchers want to understand how these treatments interact with the skin and if they are safe. Participants will receive one of three treatments: Poly-L-Lactic Acid (PLLA), Calcium Hydroxylapatite (CaHA), or Radiofrequency Microneedling (RFM). After the treatment, they will attend five follow-up appointments to check on their progress and health.

To join the trial, participants must be at least 30 years old, in good health, and planning to undergo one of these treatments for skin laxity or volume loss. They should also be able to understand the study and agree to participate. However, individuals under 30, pregnant or breastfeeding women, and those with certain medical conditions or issues in the treatment area cannot participate. This study is currently looking for volunteers who meet the criteria and want to learn more about these treatments.

Gender

ALL

Eligibility criteria

• -Inclusion Criteria:
• • 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 Criteria:
• • 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