Evaluating safety and tissue changes from injectable and energy-based biostimulatory treatments
Official title: Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
Run by Universitätsklinikum Hamburg-Eppendorf · NCT06993558 · Data updated 2026-11-12
This study is testing the safety and effects of three different biostimulatory treatments on healthy volunteers to see how they change the skin over two years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Status | Recruiting |
| Started | July 31, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | September 15, 2027 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT06993558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy men and women aged 30 years and older who are planning to undergo biostimulatory treatments for skin laxity or volume loss.
✕Probably not a fit
Patients under 30 years, pregnant or breastfeeding individuals, or those with significant skin issues in the treatment area may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety profile and tissue interactions following biostimulatory treatments in healthy volunteers. Participants will receive one of three treatments: Poly-L-Lactic Acid, Calcium Hydroxyapatite, or Radiofrequency Microneedling, and will attend five follow-up appointments for evaluations. The study will utilize photographic assessments and ultrasound imaging to monitor changes in the pre-auricular region over a period of up to 24 months.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of biostimulatory treatments for facial rejuvenation.
How similar studies have gone: While there have been studies on individual biostimulatory treatments, this specific combination and comprehensive safety analysis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
-Inclusion Criteria: Men and women aged 30 years and older Good general health, no relevant pre-existing conditions Patients planning to undergo PLLA or CAHA 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
Where it's running
-
University Hospital Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Jair Mauricio Ceron Bohorquez, M.D. — Medical Contour
- Study coordinator: Lynhda Nguyen, M.D.
- Email: l.nguyen@uke.de
- Phone: +49 40 7410 - 54289
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.