This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy VolunteersBiostimulationNCT06993558
Analysis of Safety and Tissue Interaction of Injectable Biosmulators
A study testing Poly-L-Lactic Acid (Sculptra) injection and Calcium Hydroxyapatite in people with This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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) biostimulatory interventions in healthy volunteers. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers
- What is being tested?
- Poly-L-Lactic Acid (Sculptra) injection and Calcium Hydroxyapatite
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2025to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
-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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Katarina Herberger, M.D. PHD, +49 40 7410 - 54289, k.herberger@uke.de
Lynhda Nguyen, M.D., +49 40 7410 - 54289, l.nguyen@uke.de
About this study
Official title: Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
The goal of this clinical trial is to analyse tissue changes in the pre-auricular region after injectable (Poly-L-Lactic-Acid/Calcium-Hydroxylapatit) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are:
How is the Safety Profile of injectable Biostimulatory Treatments? How are the Tissue Interactions after injectable Biostiomulatory Treatments?
Participants will:
- Recieve one of 2 possible biostumulatory treatments (PLLA/CAHA/
- Attend 4 follow-up appointments after treatment for checkups, surveillance and examinations.
Read the detailed description
Regular outclinic patients undergoing biostimulatory treatments will be invited to participate in this study involving photographic evaluations and ultrasound imaging. Following detailed oral and written explanations, patients will provide informed consent.
Participants will be assigned to one of 2 treatment groups:
- PLLA (Sculptra®, Sinclair Pharmaceuticals)
- CaHA (Radiesse®, Merz Pharma)
Treatment Protocols:
- PLLA: 1-3 sessions at intervals of 4-6 weeks
- CaHA: Single session
These interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.
Follow-Up Assessments
Patients will undergo follow-up evaluations at 3 defined time points after treatment:
- 6 weeks
- 6 months
- 12 months
- Being tested
- Poly-L-Lactic Acid (Sculptra) injection, Calcium Hydroxyapatite
- Keywords
- Ultrasound, Biostimulation, Poly-L-Lactic-Acid, Calcium-Hydroxylapatit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic Acid (Sculptra) injectionProcedure or surgery
1 to 2 sessions at intervals of 4 to 6 weeks are planned with PLLA (Sculptra®, Galderma Laboratories). PLLA will be injected into the face or neck region using a blunt cannula. For reconstitution, 7 ml of saline solution and 1 ml of 1 % lidocaine will be used. 5 minutes of massaging for 5 times a day are recommended.
Calcium HydroxyapatiteProcedure or surgery
For CaHA treatment (Radiesse®, Merz Pharma; HarmonyCa®, Allergan), 1 session is planned. The face (cheeks, jawline) or neck will be augmented using a blunt cannula, either diluted (Radiesse® 1:0.2 - 1:2) or undiluted (HarmonyCA®) depending on the product and the region being treated.
| Study group | Role | What they receive |
|---|---|---|
| Injectable Biostimulator 1 | Experimental | Injection to the face with a blunt canula Receives: Procedure: Poly-L-Lactic Acid (Sculptra) injection |
| Injectable Biostimulator 2 | Experimental | Will be injected to the face with blunt canula Receives: Procedure: Calcium Hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Reaction
The effectiveness of biostimulatory treatments relies on inducing a localized inflammatory response. Ultrasound can be used to assess vascular dynamics and edema, serving as objective markers of inflammation.
Measured: From enrollment to the end of treatment at 6-8 week
Analysis of Injected Biostimulator-Deposits
Injected deposits: In the CaHa and PLLA treatment groups, deposits will be visualized via sonographic imaging, a 3-distance Volume measurement will be performed
Measured: From enrollment to the end of treatment at 6 -8 week
Tissue Interaction
Characterized through ultrasound, focusing on the visualization of the epidermis, dermis, superficial fat layer, fibrous layer (fascia/superficial musculoaponeurotic system), deep fat layer, and periosteum.
Measured: From enrollment to the end of treatment at 6-8 weeks
Adverse Events
If AEs occur, they will be documented with photos and ultrasound, with appropriate treatment provided.
Measured: From enrollment to the end of treatment at 6-8 week
Secondary outcomes (2)
Clinical Outcome
Assessed using the Physician and Subject Global Aesthetic Improvement Scale (PGAIS, SGAIS) based on standardized 3D photo documentation.
Measured: From enrollment to the end of treatment at 6-8 week
Patient Satisfaction
Measured using a five-point Likert scale.
Measured: From enrollment to the end of treatment at 6-8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start31 Jul 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy patients scheduled for biostimulatory treatment (one of 2 different modalities) at the outpatient clinic will be enrolled in the study. Upon completion of the treatment protocol, participants will undergo a series of follow-up visits. These follow-ups will include standardized 3D photographic documentation, ultrasound assessments, as well as both patient-reported outcome measures and physician-administered evaluations/questionnaires.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynhda Nguyen, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Jair Mauricio Ceron Bohorquez, M.D., Principal investigator, Medical Contour
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993558
- Sponsor's protocol ID
- 2024-101412-BO-ff
- Other IDs
- University Hamburg Eppendorf
- Acronym
- Biostimulation
- Status last verified
- Jul 2026
- First submitted
- 19 May 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) may not be shared due to concerns about participant privacy and data protection regulations, limitations in the original informed consent, intellectual property or commercial interests, and the significant resources required to prepare and anonymize the data. Additionally, ethical considerations and institutional or regulatory policies may further restrict data sharing to ensure participant confidentiality and prevent potential misuse.
Publications
Wortsman X, Quezada N, Penaloza O, Cavallieri F, Schelke L, Velthuis P. Ultrasonographic Patterns of Calcium Hydroxyapatite According to Dilution and Mix With Hyaluronic Acid. J Ultrasound Med. 2023 Sep;42(9):2065-2072. doi: 10.1002/jum.16226. Epub 2023 Mar 27.
PubMed 36972372Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 2: Vascular Mapping. Aesthet Surg J. 2021 Oct 15;41(11):NP1633-NP1644. doi: 10.1093/asj/sjaa411.
PubMed 33954749Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 1: Standard Positions. Aesthet Surg J. 2021 Oct 15;41(11):NP1621-NP1632. doi: 10.1093/asj/sjaa410.
PubMed 33954581Wortsman X, Alfageme F, Roustan G, Arias-Santiago S, Martorell A, Catalano O, Scotto di Santolo M, Zarchi K, Bouer M, Gonzalez C, Bard R, Mandava A, Gaitini D. Guidelines for Performing Dermatologic Ultrasound Examinations by the DERMUS Group. J Ultrasound Med. 2016 Mar;35(3):577-80. doi: 10.7863/ultra.15.06046. Epub 2016 Feb 17.
PubMed 26887446Kyriazidis I, Spyropoulou GA, Zambacos G, Tagka A, Rakhorst HA, Gasteratos K, Berner JE, Mandrekas A. Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies. Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10.
PubMed 37563436Pavicic T. Complete biodegradable nature of calcium hydroxylapatite after injection for malar enhancement: an MRI study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:19-25. doi: 10.2147/CCID.S72878. eCollection 2015.
PubMed 25709485Amselem M. Radiesse((R)): a novel rejuvenation treatment for the upper arms. Clin Cosmet Investig Dermatol. 2015 Dec 29;9:9-14. doi: 10.2147/CCID.S93137. eCollection 2016.
PubMed 26766918Yutskovskaya Y, Kogan E, Leshunov E. A randomized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014 Sep;13(9):1047-52.
PubMed 25226004
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
- ClinicalTrials.gov ID
- NCT06993558
- Acronym / sponsor ID
- Biostimulation / 2024-101412-BO-ff
- Keywords
- Ultrasound, Biostimulation, Poly-L-Lactic-Acid, Calcium-Hydroxylapatit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to analyse tissue changes in the pre-auricular region after injectable (Poly-L-Lactic-Acid/Calcium-Hydroxylapatit) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are:
How is the Safety Profile of injectable Biostimulatory Treatments? How are the Tissue Interactions after injectable Biostiomulatory Treatments?
Participants will:
- Recieve one of 2 possible biostumulatory treatments (PLLA/CAHA/
- Attend 4 follow-up appointments after treatment for checkups, surveillance and examinations.
Detailed description
Regular outclinic patients undergoing biostimulatory treatments will be invited to participate in this study involving photographic evaluations and ultrasound imaging. Following detailed oral and written explanations, patients will provide informed consent.
Participants will be assigned to one of 2 treatment groups:
- PLLA (Sculptra®, Sinclair Pharmaceuticals)
- CaHA (Radiesse®, Merz Pharma)
Treatment Protocols:
- PLLA: 1-3 sessions at intervals of 4-6 weeks
- CaHA: Single session
These interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.
Follow-Up Assessments
Patients will undergo follow-up evaluations at 3 defined time points after treatment:
- 6 weeks
- 6 months
- 12 months
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy patients scheduled for biostimulatory treatment (one of 2 different modalities) at the outpatient clinic will be enrolled in the study. Upon completion of the treatment protocol, participants will undergo a series of follow-up visits. These follow-ups will include standardized 3D photographic documentation, ultrasound assessments, as well as both patient-reported outcome measures and physician-administered evaluations/questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Injectable Biostimulator 1 | Experimental | Procedure: Poly-L-Lactic Acid (Sculptra) injectionInjection to the face with a blunt canula |
| Injectable Biostimulator 2 | Experimental | Procedure: Calcium HydroxyapatiteWill be injected to the face with blunt canula |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injection1 to 2 sessions at intervals of 4 to 6 weeks are planned with PLLA (Sculptra®, Galderma Laboratories). PLLA will be injected into the face or neck region using a blunt cannula. For reconstitution, 7 ml of saline solution and 1 ml of 1 % lidocaine will be used. 5 minutes of massaging for 5 times a day are recommended. | Procedure or surgery | Injectable Biostimulator 1 |
| Calcium HydroxyapatiteFor CaHA treatment (Radiesse®, Merz Pharma; HarmonyCa®, Allergan), 1 session is planned. The face (cheeks, jawline) or neck will be augmented using a blunt cannula, either diluted (Radiesse® 1:0.2 - 1:2) or undiluted (HarmonyCA®) depending on the product and the region being treated. | Procedure or surgery | Injectable Biostimulator 2 |
Primary outcome
Inflammatory Reaction
Time frame: From enrollment to the end of treatment at 6-8 week
The effectiveness of biostimulatory treatments relies on inducing a localized inflammatory response. Ultrasound can be used to assess vascular dynamics and edema, serving as objective markers of inflammation.
Analysis of Injected Biostimulator-Deposits
Time frame: From enrollment to the end of treatment at 6 -8 week
Injected deposits: In the CaHa and PLLA treatment groups, deposits will be visualized via sonographic imaging, a 3-distance Volume measurement will be performed
Tissue Interaction
Time frame: From enrollment to the end of treatment at 6-8 weeks
Characterized through ultrasound, focusing on the visualization of the epidermis, dermis, superficial fat layer, fibrous layer (fascia/superficial musculoaponeurotic system), deep fat layer, and periosteum.
Adverse Events
Time frame: From enrollment to the end of treatment at 6-8 week
If AEs occur, they will be documented with photos and ultrasound, with appropriate treatment provided.
2 secondary outcomes
Clinical Outcome
Time frame: From enrollment to the end of treatment at 6-8 week
Patient Satisfaction
Time frame: From enrollment to the end of treatment at 6-8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 36972372Wortsman X, Quezada N, Penaloza O, Cavallieri F, Schelke L, Velthuis P. Ultrasonographic Patterns of Calcium Hydroxyapatite According to Dilution and Mix With Hyaluronic Acid. J Ultrasound Med. 2023 Sep;42(9):2065-2072. doi: 10.1002/jum.16226. Epub 2023 Mar 27.
- Background: PubMed 33954749Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 2: Vascular Mapping. Aesthet Surg J. 2021 Oct 15;41(11):NP1633-NP1644. doi: 10.1093/asj/sjaa411.
- Background: PubMed 33954581Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 1: Standard Positions. Aesthet Surg J. 2021 Oct 15;41(11):NP1621-NP1632. doi: 10.1093/asj/sjaa410.
- Background: PubMed 26887446Wortsman X, Alfageme F, Roustan G, Arias-Santiago S, Martorell A, Catalano O, Scotto di Santolo M, Zarchi K, Bouer M, Gonzalez C, Bard R, Mandava A, Gaitini D. Guidelines for Performing Dermatologic Ultrasound Examinations by the DERMUS Group. J Ultrasound Med. 2016 Mar;35(3):577-80. doi: 10.7863/ultra.15.06046. Epub 2016 Feb 17.
- Background: PubMed 37563436Kyriazidis I, Spyropoulou GA, Zambacos G, Tagka A, Rakhorst HA, Gasteratos K, Berner JE, Mandrekas A. Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies. Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10.
- Background: PubMed 25709485Pavicic T. Complete biodegradable nature of calcium hydroxylapatite after injection for malar enhancement: an MRI study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:19-25. doi: 10.2147/CCID.S72878. eCollection 2015.
- Background: PubMed 26766918Amselem M. Radiesse((R)): a novel rejuvenation treatment for the upper arms. Clin Cosmet Investig Dermatol. 2015 Dec 29;9:9-14. doi: 10.2147/CCID.S93137. eCollection 2016.
- Results publication: PubMed 25226004Yutskovskaya Y, Kogan E, Leshunov E. A randomized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014 Sep;13(9):1047-52.
- American Society of Plastic Surgeons Reveals 2022's Most Sought-After ProceduresLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) may not be shared due to concerns about participant privacy and data protection regulations, limitations in the original informed consent, intellectual property or commercial interests, and the significant resources required to prepare and anonymize the data. Additionally, ethical considerations and institutional or regulatory policies may further restrict data sharing to ensure participant confidentiality and prevent potential misuse.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jair Mauricio Ceron Bohorquez, M.D. principal investigator
Medical Contour
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-Lactic Acid (Sculptra) injection and Calcium Hydroxyapatite in people with This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynhda Nguyen, M.D. (+49 40 7410 - 54289, l.nguyen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Reaction (time frame: From enrollment to the end of treatment at 6-8 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06993558, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.