Evaluating safety and tissue changes from injectable and energy-based biostimulatory treatments
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators.
NA · Universitätsklinikum Hamburg-Eppendorf · NCT06993558
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT06993558 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there have been studies on individual biostimulatory treatments, this specific combination and comprehensive safety analysis is relatively novel.
Eligibility criteria
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 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
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers, Ultrasound, Biostimulation, Poly-L-Lactic-Acid, Calcium-Hydroxylapatit, Radio Frequency Microneedling