Décolleté WrinklesNCT07086248
A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments
A study testing Radiesse in people with Décolleté Wrinkles, run by Merz North America, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Décolleté Wrinkles
- What is being tested?
- Radiesse
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to Nov 2026
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants seeking improvement of moderate to severe décolleté wrinkles.
- Participant is willing to undergo up to three bilateral mammograms and up to four bilateral ultrasound procedures.
Who cannot join
- Any pre-existing serious disease or disorder of the breast tissue that may confound interpretation of radiographic and/or ultrasound imaging (example., participants with a history of breast cancer or an immediate family history of breast cancer [that is., mother, sister, and/or daughter], pathogenic or likely pathogenic breast cancer (BRCA) gene variant, calcifications and/or microcalcifications detected on previous mammography [up to three years prior to study start, if available]).
- Present uncontrolled malignant disease.
- Any condition that would caution against receiving additional radiation exposure in the breasts.
- Any previous surgery, including plastic surgery or permanent surgical implant, or previous non-surgical treatment in the planned in the treatment area and in the breasts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter, Single-arm, Uncontrolled Safety Study to Assess Radiographic Imaging Following Treatment With RADIESSE® Dilute in the Décolleté in Adult Females in the United States
The primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue.
- Conditions
- Décolleté Wrinkles
- Being tested
- Radiesse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiesseDevice
Radiesse injections diluted 1:2 with sterile saline.
| Study group | Role | What they receive |
|---|---|---|
| Radiesse | Experimental | Participants will receive three injections of Radiesse in the Décolleté at Weeks 1, 7 and 13. Receives: Device: Radiesse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Interference of Radiesse Dilute in Either Breast Observed in Breast Ultrasound or Mammogram Images at Week 17, As Assessed By an Adjudication Committee Composed of Two Board-certified Radiologists
Interference is defined as a "Yes" response to questions (Q) Q2, Q3, Q5, or Q6 by at least one adjudication committee member. The questionnaire includes six questions assessing product visibility on breast imaging and its impact on diagnostic interpretation. For ultrasound: Q1 asks if the product is visible on the assessed breast ultrasound image(s) (Yes/No). If visible, Q2 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q3 asks if it may cause a false positive leading to additional screening or unnecessary biopsies (Yes/No). For mammography: Q4 asks if the product is visible on the assessed mammogram image(s) (Yes/No). If visible, Q5 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q6 asks if it may cause a false positive leading to further screening or unnecessary biopsies (Yes/No).
Measured: Week 17
Secondary outcomes (1)
Occurrence of Adverse Events (AEs) Related to Treatment With Radiesse Dilute, as Reported By the Treating Investigator Throughout the Study
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE is considered to be related if a causal relationship between Radiesse Dilute and the AE is at least reasonably possible.
Measured: Baseline up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start22 Jul 2025
- Primary completion26 Jan 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Décolleté WrinklesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086248
- Sponsor's protocol ID
- RAD-DEC-US001
- Status last verified
- May 2026
- First submitted
- 7 Jul 2025
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Single-arm, Uncontrolled Safety Study to Assess Radiographic Imaging Following Treatment With RADIESSE® Dilute in the Décolleté in Adult Females in the United States
- ClinicalTrials.gov ID
- NCT07086248
- Acronym / sponsor ID
- RAD-DEC-US001
- Conditions
- Décolleté Wrinkles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Jul 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 primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiesse | Experimental | Device: RadiesseParticipants will receive three injections of Radiesse in the Décolleté at Weeks 1, 7 and 13. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants seeking improvement of moderate to severe décolleté wrinkles.
- Participant is willing to undergo up to three bilateral mammograms and up to four bilateral ultrasound procedures.
Key exclusion criteria (4 listed)
- Any pre-existing serious disease or disorder of the breast tissue that may confound interpretation of radiographic and/or ultrasound imaging (example., participants with a history of breast cancer or an immediate family history of breast cancer [that is., mother, sister, and/or daughter], pathogenic or likely pathogenic breast cancer (BRCA) gene variant, calcifications and/or microcalcifications detected on previous mammography [up to three years prior to study start, if available]).
- Present uncontrolled malignant disease.
- Any condition that would caution against receiving additional radiation exposure in the breasts.
- Any previous surgery, including plastic surgery or permanent surgical implant, or previous non-surgical treatment in the planned in the treatment area and in the breasts.
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 |
|---|---|---|
| RadiesseRadiesse injections diluted 1:2 with sterile saline. | Device | Radiesse |
Primary outcome
Any Interference of Radiesse Dilute in Either Breast Observed in Breast Ultrasound or Mammogram Images at Week 17, As Assessed By an Adjudication Committee Composed of Two Board-certified Radiologists
Time frame: Week 17
Interference is defined as a "Yes" response to questions (Q) Q2, Q3, Q5, or Q6 by at least one adjudication committee member. The questionnaire includes six questions assessing product visibility on breast imaging and its impact on diagnostic interpretation. For ultrasound: Q1 asks if the product is visible on the assessed breast ultrasound image(s) (Yes/No). If visible, Q2 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q3 asks if it may cause a false positive leading to additional screening or unnecessary biopsies (Yes/No). For mammography: Q4 asks if the product is visible on the assessed mammogram image(s) (Yes/No). If visible, Q5 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q6 asks if it may cause a false positive leading to further screening or unnecessary biopsies (Yes/No).
1 secondary outcome
Occurrence of Adverse Events (AEs) Related to Treatment With Radiesse Dilute, as Reported By the Treating Investigator Throughout the Study
Time frame: Baseline up to Week 60
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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
Merz Medical Expert 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 Radiesse in people with Décolleté Wrinkles, run by Merz North America, Inc. at 1 site in United States.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 May 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 United States. 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?
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?
Any Interference of Radiesse Dilute in Either Breast Observed in Breast Ultrasound or Mammogram Images at Week 17, As Assessed By an Adjudication Committee Composed of Two Board-certified Radiologists (time frame: Week 17). 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 8 May 2026.