NCT06993558 Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
| NCT ID | NCT06993558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-03-22 |
| Primary Completion | 2026-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-03-22 with a primary completion date of 2026-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jair Mauricio Ceron Bohorquez, M.D.
PRINCIPAL INVESTIGATOR
Medical Contour
Frequently Asked Questions
Who can join the NCT06993558 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06993558 currently recruiting?
Yes, NCT06993558 is actively recruiting participants. Contact the research team at l.nguyen@uke.de for enrollment information.
Where is the NCT06993558 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT06993558 clinical trial?
NCT06993558 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Jair Mauricio Ceron Bohorquez, M.D. at Medical Contour. The trial plans to enroll 90 participants.