Injection Site ReactionNCT06093815
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
A study testing Injection in people with Injection Site Reaction, run by Merz North America, Inc. at 1 site in Spain.
Trial summary
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study. Safety endpoint: incidence of adverse events. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Reaction
- What is being tested?
- Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male \& females; 22 to 65 years of age.
- Voluntary participation
- Ability to comprehend and provide informed consent.
- Participants agree NOT to use any topical agents or products that will induce skin peeling or change the appearance of the skin in the treatment area, during the study period.
- Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
- Participants agree NOT to undergo any surgical treatments in the treatment area during the study period.
- Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.
Who cannot join
- Any previous surgery in the abdominal area.
- Any previous treatment in the abdominal area.
- Planning to receive treatment of any kind in the abdominal area.
- Acute inflammatory process and/or infection at the injection site.
- Treatment of skin area with dermatosis.
- Eczema, exanthema or open wounds.
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- Previous application of over the counter or prescription, oral or topical, anti-wrinkle or skin enhancer products on the abdominal skin within the past 3 months unless allowed by the study and is continued throughout the study.
- Any contraindication to treatment with biostimulatory products based on the product's IFU.
- Previous pregnancy or intending to become pregnant during study participation.
- Known hypersensitivity to biostimulatory products or any of their formulation ingredients.
- Allergic reaction to topical and local anesthetics.
- Currently using anticoagulant therapy.
- Haemophilia / bleeding disorder.
- Chemotherapy, radiotherapy or high doses of corticosteroids.
- Systemic infection (e.g., hepatitis).
- Uncontrolled diabetes mellitus.
- Any medical condition that may put the participant at increased risk with exposure to biostimulatory products.
- Any medication that might modulate the immune response.
- Any other illness or condition that, in the opinion of the investigator, would mean that study participation was not in the best interest of the prospective participant.
- Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating.
- Any serious disease or disorder (medical or psychiatric) that could, in the opinion of the investigator, interfere with the safe completion of treatment according to this protocol or with study.
- Injection of local anesthesia into the flap during abdominoplasty surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single Site, Controlled Comparative Study to Identify and Assess Tissue Responses After Injection With Various Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.
Safety endpoint: incidence of adverse events.
Read the detailed description
The objective of this study is to identify and assess tissue responses after injection with various biostimulatory products that are already used in the market and have CE approval. The study will assess in vivo tissue responses and provide tissue specimens which will be used in a subsequent study, under a separate protocol.
Assessments under this protocol will include ultrasound of in vivo tissue.
Safety endpoint: incidence of adverse events.
- Conditions
- Injection Site Reaction
- Being tested
- Injection
- Medical subject headings
- Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectionDevice
A pre specified amount will be injected in tissue at selected timepoints
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Subjects in Arm 1 will receive injections of biostimulatory products (Radiesse(+) undiluted, Radiesse diluted 1:1, Radiesse diluted 1:2, Sculptra, Ellanse, HArmonyCa) at 3 timepoints (six months, three months and two weeks) prior to removal of redundant abdominal tissue. Receives: Device: Injection |
| Arm 2 - Radiesse Classic (1:1 Dilution) | Experimental | Five participants in Arm 2 will receive Radiesse Classic diluted 1:1 with sterile saline (CaHA-CMC 1:1) and saline control injections at separate predefined abdominal injection sites. All injections will be administered at a single protocol-defined timepoint, 6 months prior to removal of redundant abdominal tissue. Receives: Device: Injection |
| Arm 2 - Sculptra | Experimental | Five participants in Arm 2 will receive Sculptra diluted with 5 mL of sterile saline and saline control injections at separate predefined abdominal injection sites. All injections will be administered at a single protocol-defined timepoint, 6 months prior to removal of redundant abdominal tissue. Receives: Device: Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1 - Ultrasound Analyses - Skin Thickness (mm)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Measured: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Arm 1 - Ultrasound Analyses - Elastosis
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade.
Measured: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Arm 1 - Ultrasound Analyses - Microvascular Formation
Microvascular formation assessed by ultrasound at the injection site and reported according to the study-defined category/grade.
Measured: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Arm 2 - Ultrasound Analyses - Skin Thickness (mm)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Measured: 6 months prior to surgery timepoint(s)
Arm 2 - Ultrasound Analyses - Elastosis
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade
Measured: 6 months prior to surgery timepoint(s)
Arm 2 - Ultrasound Analyses - Microvascular Formation
Microvascular formation assessed by ultrasound at injection site and reported according to the study-defined category/grade.
Measured: 6 months prior to surgery timepoint(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start8 Sep 2023
- Primary completion1 May 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injection Site ReactionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Injections will be in redundant abdominal tissue scheduled to be removed at end of study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann P Marx, MD, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093815
- Sponsor's protocol ID
- M900311010
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2023
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: individual data will be summarized for analyses
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Site, Controlled Comparative Study to Identify and Assess Tissue Responses After Injection With Various Biostimulatory Products
- ClinicalTrials.gov ID
- NCT06093815
- Acronym / sponsor ID
- M900311010
- Conditions
- Injection Site Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.
Safety endpoint: incidence of adverse events.
Detailed description
The objective of this study is to identify and assess tissue responses after injection with various biostimulatory products that are already used in the market and have CE approval. The study will assess in vivo tissue responses and provide tissue specimens which will be used in a subsequent study, under a separate protocol.
Assessments under this protocol will include ultrasound of in vivo tissue.
Safety endpoint: incidence of adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Injections will be in redundant abdominal tissue scheduled to be removed at end of study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: InjectionSubjects in Arm 1 will receive injections of biostimulatory products (Radiesse(+) undiluted, Radiesse diluted 1:1, Radiesse diluted 1:2, Sculptra, Ellanse, HArmonyCa) at 3 timepoints (six months, three months and two weeks) prior to removal of redundant abdominal tissue. |
| Arm 2 - Radiesse Classic (1:1 Dilution) | Experimental | Device: InjectionFive participants in Arm 2 will receive Radiesse Classic diluted 1:1 with sterile saline (CaHA-CMC 1:1) and saline control injections at separate predefined abdominal injection sites. All injections will be administered at a single protocol-defined timepoint, 6 months prior to removal of redundant abdominal tissue. |
| Arm 2 - Sculptra | Experimental | Device: InjectionFive participants in Arm 2 will receive Sculptra diluted with 5 mL of sterile saline and saline control injections at separate predefined abdominal injection sites. All injections will be administered at a single protocol-defined timepoint, 6 months prior to removal of redundant abdominal tissue. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male \& females; 22 to 65 years of age.
- Voluntary participation
- Ability to comprehend and provide informed consent.
- Participants agree NOT to use any topical agents or products that will induce skin peeling or change the appearance of the skin in the treatment area, during the study period.
- Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
Key exclusion criteria (22 listed)
- Any previous surgery in the abdominal area.
- Any previous treatment in the abdominal area.
- Planning to receive treatment of any kind in the abdominal area.
- Acute inflammatory process and/or infection at the injection site.
- Treatment of skin area with dermatosis.
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 |
|---|---|---|
| InjectionA pre specified amount will be injected in tissue at selected timepoints | Device | Arm 1, Arm 2 - Radiesse Classic (1:1 Dilution), Arm 2 - Sculptra |
Primary outcome
Arm 1 - Ultrasound Analyses - Skin Thickness (mm)
Time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Arm 1 - Ultrasound Analyses - Elastosis
Time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade.
Arm 1 - Ultrasound Analyses - Microvascular Formation
Time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Microvascular formation assessed by ultrasound at the injection site and reported according to the study-defined category/grade.
Arm 2 - Ultrasound Analyses - Skin Thickness (mm)
Time frame: 6 months prior to surgery timepoint(s)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Arm 2 - Ultrasound Analyses - Elastosis
Time frame: 6 months prior to surgery timepoint(s)
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade
Arm 2 - Ultrasound Analyses - Microvascular Formation
Time frame: 6 months prior to surgery timepoint(s)
Microvascular formation assessed by ultrasound at injection site and reported according to the study-defined category/grade.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. individual data will be summarized for analyses
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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. This study is not recruiting at the moment.
Ann P Marx, MD study director
Merz North America, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection in people with Injection Site Reaction, run by Merz North America, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Sep 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 Spain. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 1 - Ultrasound Analyses - Skin Thickness (mm) (time frame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.