An interventional study of Injection in Injection Site Reaction, sponsored by Merz North America, Inc.. Completed at 1 site in Spain. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Merz North America, Inc. (part of Merz Pharma) · Not applicable, Interventional, and Basic science
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.
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.
22 studies on the registry are indexed under Injection Site Reaction; 3 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 17 interventional studies indexed under Injection Site Reaction.
Browse Injection Site Reaction studies →Merz North America, Inc. is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 19 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Injection
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.
Device: Injection
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.
Device: Injection
A pre specified amount will be injected in tissue at selected timepoints
Arm 1 - Ultrasound Analyses - Skin Thickness (mm)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Time frame: 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.
Time frame: 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.
Time frame: 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))
Time frame: 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
Time frame: 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.
Time frame: 6 months prior to surgery timepoint(s)
Safety Assessment
Any patient- or investigator-observed adverse event
Time frame: through study completion, an average of 6 months
| Milestone | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra |
|---|---|---|---|
| Started | 10 | 5 | 5 |
| Received 6-month injection set | 10 | 5 | 5 |
| Received 3-month injection set | 10 | 0 | 0 |
| Received 14-day injection set | 10 | 0 | 0 |
| Completed | 10 | 5 | 5 |
| Not completed | 0 | 0 | 0 |
Ultrasound of injection site tissue analyses (dermal thickness (mm))
| mm | Saline Control | Radiesse (+) | Radiesse Classic (1:1 Dilution) | Radiesse Classic (1:2 Dilution) | Sculptra | HArmonyCa | Ellanse |
|---|---|---|---|---|---|---|---|
| Baseline | 1.75 ± .33 | 1.75 ± .29 | 1.76 ± .36 | 1.67 ± .32 | 1.76 ± .37 | 1.76 ± .22 | 1.73 ± .25 |
| Day 14 | 1.84 ± .28 | 1.96 ± .30 | 2.01 ± .30 | 1.76 ± .21 | 1.80 ± .31 | 1.74 ± .32 | 1.85 ± .12 |
| Month 3 | 1.69 ± .34 | 1.99 ± .33 | 2.08 ± .41 | 1.83 ± .30 | 1.74 ± .52 | 1.83 ± .29 | 1.78 ± .27 |
| Month 6 | 1.73 ± .33 | 1.89 ± .37 | 2.04 ± .33 | 1.78 ± .25 | 1.64 ± .31 | 1.92 ± .19 | 1.65 ± .31 |
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade.
| Participants | Saline Control | Radiesse (+) | Radiesse Classic (1:1 Dilution) | Radiesse Classic (1:2 Dilution) | Sculptra | HArmonyCa | Ellanse |
|---|---|---|---|---|---|---|---|
| Baseline — Continuous | 5 | 7 | 6 | 4 | 4 | 6 | 6 |
| Baseline — Focal | 5 | 3 | 4 | 6 | 5 | 2 | 2 |
| Baseline — None | 0 | 0 | 0 | 0 | 1 | 2 | 2 |
| Day 14 — Continuous | 4 | 2 | 0 | 0 | 3 | 2 | 5 |
| Day 14 — Focal | 4 | 6 | 5 | 5 | 6 | 7 | 3 |
| Day 14 — None | 2 | 2 | 5 | 5 | 1 | 1 | 2 |
| Month 3 — Continuous | 6 | 4 | 1 | 2 | 5 | 4 | 6 |
| Month 3 — Focal | 4 | 2 | 3 | 4 | 3 | 4 | 4 |
| Month 3 — None | 0 | 4 | 6 | 4 | 2 | 2 | 0 |
| Month 6 — Continuous | 3 | 1 | 0 | 2 | 2 | 6 | 1 |
| Month 6 — Focal | 5 | 8 | 4 | 5 | 6 | 4 | 6 |
| Month 6 — None | 2 | 1 | 6 | 3 | 2 | 0 | 3 |
Microvascular formation assessed by ultrasound at the injection site and reported according to the study-defined category/grade.
| Participants | Saline Control | Radiesse (+) | Radiesse Classic (1:1 Dilution) | Radiesse Classic (1:2 Dilution) | Sculptra | HArmonyCa | Ellanse |
|---|---|---|---|---|---|---|---|
| Baseline — Augmented | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Baseline — Normal | 10 | 10 | 10 | 10 | 10 | 10 | 9 |
| Baseline — Diminished | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Day 14 — Augmented | 4 | 8 | 8 | 9 | 6 | 5 | 8 |
| Day 14 — Normal | 6 | 2 | 2 | 1 | 4 | 5 | 2 |
| Day 14 — Diminished | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Month 3 — Augmented | 0 | 7 | 6 | 6 | 6 | 8 | 5 |
| Month 3 — Normal | 10 | 3 | 4 | 4 | 4 | 2 | 5 |
| Month 3 — Diminished | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Month 6 — Augmented | 3 | 9 | 10 | 5 | 6 | 9 | 5 |
| Month 6 — Normal | 7 | 1 | 0 | 5 | 4 | 1 | 5 |
| Month 6 — Diminished | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Ultrasound of injection site tissue analyses (dermal thickness (mm))
| mm | Radiesse Classic (1:1 Dilution) | Sculptra | Saline |
|---|---|---|---|
| Baseline | 1.77 ± .40 | 1.75 ± .32 | 1.62 ± .34 |
| Month 6 | 2.08 ± .64 | 1.46 ± .18 | 1.61 ± .35 |
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade
| Participants | Radiesse Classic (1:1 Dilution) | Sculptra | Saline |
|---|---|---|---|
| Baseline — Continuous | 2 | 3 | 2 |
| Baseline — Focal | 2 | 2 | 5 |
| Baseline — None | 1 | 0 | 3 |
| Month 6 — Continuous | 2 | 3 | 2 |
| Month 6 — Focal | 2 | 2 | 5 |
| Month 6 — None | 1 | 0 | 3 |
Microvascular formation assessed by ultrasound at injection site and reported according to the study-defined category/grade.
| Participants | Radiesse Classic (1:1 Dilution) | Sculptra | Saline |
|---|---|---|---|
| Baseline — Augmented | 0 | 0 | 0 |
| Baseline — Normal | 5 | 5 | 10 |
| Baseline — Diminished | 0 | 0 | 0 |
| Month 6 — Augmented | 5 | 4 | 2 |
| Month 6 — Normal | 0 | 1 | 8 |
| Month 6 — Diminished | 0 | 0 | 0 |
Any patient- or investigator-observed adverse event
| Participants | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra |
|---|---|---|---|
| Safety Assessment | 0 | 0 | 0 |
Collected over From first study injection through final study follow-up (up to 6 months after injection and day of surgery).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 - Radiesse (+) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 1 - Radiesse Classic Diluted 1:1 | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 1 - Radiesse Classic Diluted 1:2 | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 1 - Sculptra | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 1 - HarmonyCa | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 1 - Ellanse | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 1 - Sterile Saline | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Arm 2 - Radiesse Classic Diluted 1:1 | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Arm 2 - Sculptra | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Arm 2 - Sterile Saline | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
Baseline characteristics were summarized at the participant level according to the assigned Arm/Group: Arm 1, Arm 2 - Radiesse Classic (1:1 Dilution), and Arm 2 - Sculptra.
| Age, Continuous(years) | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra | Total |
|---|---|---|---|---|
| Mean | 50 ± 9.2 | 49.6 ± 6.5 | 48 ± 7.2 | 49.4 ± 7.9 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra | Total |
|---|---|---|---|---|
| Female | 9 | 5 | 2 | 16 |
| Male | 1 | 0 | 3 | 4 |
| Race and Ethnicity Not Collected(Participants) | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra | Total |
|---|---|---|---|---|
| Spain | 10 | 5 | 5 | 20 |
| Fitzpatrick Skin Type(Participants) | Arm 1 | Arm 2 - Radiesse Classic (1:1 Dilution) | Arm 2 - Sculptra | Total |
|---|---|---|---|---|
| FST 1 - Never tans, always burns | 0 | 0 | 0 | 0 |
| FST II - Usually burns, sometimes tans | 1 | 0 | 2 | 3 |
| FST III - Sometimes burns, usually tans | 7 | 5 | 3 | 15 |
| FST IV - Rarely burns, always tans | 2 | 0 | 0 | 2 |
| FST V - Very rarely burns, always tans | 0 | 0 | 0 | 0 |
| FST VI - Never burns, always tans | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — individual data will be summarized for analyses
Ran from Sep 2023 to primary completion in May 2024, 7 months.
Results were first posted in Sep 2026, 2 years 4 months after primary completion.
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