Skin LaxityPhase 1NCT04176068
Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration
A Phase 1 study testing calcium hydroxylapatite (Radiesse) and IFUS (Ulthera) in people with Skin Laxity, run by University of California, Irvine at 1 site in United States.
Trial summary
Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 1 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician.
- Subjects between the ages of 18-85 years old, at the time of consent.
- Subjects may be male or female.
- Subjects can be of any Fitzpatrick Skin type (I-VI).
- Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand.
Who cannot join
- Children and adolescents (less than 18 years old).
- Subjects who are not willing or able to provide written consent.
- Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
- Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
- Subjects with known blood coagulopathies.
- Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the lower thigh such as lupus, morphea, sarcoid or mixed connective tissue disease).
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- Subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks.
- Subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks.
- Subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product.
- Subjects with open wounds in the area of ultrasound treatment.
- Subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment.
- Female patients who are planning a pregnancy, currently pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Dermatology Clinical Research Center
Irvine, California, 92697
About this study
Official title: Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity
Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers have started combining modalities together such as focused ultrasound and intradermal filler, with promising effects for skin laxity and volume restoration. This study aims to elucidate the efficacy and added benefits of a combination therapy using focused ultrasound (Ulthera) and calcium hydroxylapatite (Radiesse) for the treatment of skin laxity and volume restoration of the lower thighs, specifically the lower anterior third of the thigh.
- Conditions
- Skin Laxity
- Being tested
- calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)Combination product
Also called intense microfocused ultrasound
Patients will receive IFUS to a randomly chosen side. Immediately after IFUS treatment, patients will receive the first CaHA injection. Injections will be given in the lower, anterior third of the thigh, above the knee. Only dermatology faculty will perform the filler injections. The patients will be instructed to return to the office in 6 weeks, 12 weeks, and 24 weeks (+/- 5 business days) for their next appointment for follow-up and injection of CaHA if deemed necessary by the investigator. At all visits (Visits 1-4) patients will have photographs and unblinded physician/patient questionnaires will be completed. At Visit 4 (24 weeks +/- 5 business days), patients will be given the option to receive treatment for skin laxity to the previously untreated side. If the patient chooses to receive treatment, patients will receive their second IFUS and CaHA combination treatment at this time. They will not receive further treatment after this visit.
| Study group | Role | What they receive |
|---|---|---|
| Combined microfocused ultrasound and calcium hydroxylapatite | Experimental | One-time intense microfocused ultrasound with calcium hydroxylapatite injection to one anterior lower thigh with option for additional filler injection at 6 weeks, 12 weeks, and 24 weeks. Optional combined treatment of the opposite lower anterior thigh at week 24 with no further follow up. Receives: Combination Product: calcium hydroxylapatite (Radiesse) and IFUS (Ulthera) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of combined therapy at 12 weeks
To determine the efficacy of intense focused ultrasound (IFUS) + calcium hydroxylapatite (CaHA) filler for the correction of skin laxity of the lower thigh as assessed by a blinded and an unblinded physician Global Aesthetic Improvement Scale (scale 1-7 with 1 being much improved and 7 being much worse) at 12 weeks.
Measured: 12 weeks
Secondary outcomes (3)
Efficacy of combined therapy at 24 weeks
To determine the efficacy of IFUS and CaHA filler for the correction of skin laxity of the lower thigh as assessed by a blinded and an unblinded physician Global Aesthetic Improvement Scale (scale 1-7 with 1 being much improved and 7 being much worse) at 24 weeks.
Measured: 24 weeks
Efficacy with Merz Aesthetic scale at 12 and 24 weeks
To determine the efficacy of IFUS and CaHA filler for the correction of skin laxity of the lower thigh as assessed by a blinded and an unblinded physician Merz Aesthetic Scale (Grade 0-4 with 0 being no skin laxity and 4 being very severe skin laxity) at 12 and 24 weeks.
Measured: 24 weeks
Patient satisfaction at 24 weeks
To determine patient satisfaction 24 weeks post-treatment of IFUS + CaHA for the treatment of skin laxity of the lower thigh as assessed on a scale of 0-10 (with 0 being not satisfied and 10 being very satisfied).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start19 Apr 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Mesinkovska, University of California, Irvine
- Investigators
- Natasha Mesinkovska, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176068
- Sponsor's protocol ID
- 20184856
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity
- ClinicalTrials.gov ID
- NCT04176068
- Acronym / sponsor ID
- 20184856
- Conditions
- Skin Laxity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 25 Nov 2019 (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.
Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers have started combining modalities together such as focused ultrasound and intradermal filler, with promising effects for skin laxity and volume restoration. This study aims to elucidate the efficacy and added benefits of a combination therapy using focused ultrasound (Ulthera) and calcium hydroxylapatite (Radiesse) for the treatment of skin laxity and volume restoration of the lower thighs, specifically the lower anterior third of the thigh.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined microfocused ultrasound and calcium hydroxylapatite | Experimental | Combination Product: calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)One-time intense microfocused ultrasound with calcium hydroxylapatite injection to one anterior lower thigh with option for additional filler injection at 6 weeks, 12 weeks, and 24 weeks. Optional combined treatment of the opposite lower anterior thigh at week 24 with no further follow up. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician.
- Subjects between the ages of 18-85 years old, at the time of consent.
- Subjects may be male or female.
- Subjects can be of any Fitzpatrick Skin type (I-VI).
- Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand.
Key exclusion criteria (12 listed)
- Children and adolescents (less than 18 years old).
- Subjects who are not willing or able to provide written consent.
- Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
- Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
- Subjects with known blood coagulopathies.
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 |
|---|---|---|
| calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)Also: intense microfocused ultrasoundPatients will receive IFUS to a randomly chosen side. Immediately after IFUS treatment, patients will receive the first CaHA injection. Injections will be given in the lower, anterior third of the thigh, above the knee. Only dermatology faculty will perform the filler injections. The patients will be instructed to return to the office in 6 weeks, 12 weeks, and 24 weeks (+/- 5 business days) for their next appointment for follow-up and injection of CaHA if deemed necessary by the investigator. At all visits (Visits 1-4) patients will have photographs and unblinded physician/patient questionnaires will be completed. At Visit 4 (24 weeks +/- 5 business days), patients will be given the option to receive treatment for skin laxity to the previously untreated side. If the patient chooses to receive treatment, patients will receive their second IFUS and CaHA combination treatment at this time. They will not receive further treatment after this visit. | Combination product | Combined microfocused ultrasound and calcium hydroxylapatite |
Primary outcome
Efficacy of combined therapy at 12 weeks
Time frame: 12 weeks
To determine the efficacy of intense focused ultrasound (IFUS) + calcium hydroxylapatite (CaHA) filler for the correction of skin laxity of the lower thigh as assessed by a blinded and an unblinded physician Global Aesthetic Improvement Scale (scale 1-7 with 1 being much improved and 7 being much worse) at 12 weeks.
3 secondary outcomes
Efficacy of combined therapy at 24 weeks
Time frame: 24 weeks
Efficacy with Merz Aesthetic scale at 12 and 24 weeks
Time frame: 24 weeks
Patient satisfaction at 24 weeks
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- 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.
Natasha Mesinkovska, MD, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing calcium hydroxylapatite (Radiesse) and IFUS (Ulthera) in people with Skin Laxity, run by University of California, Irvine 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 5 inclusion and 12 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 2 Feb 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of combined therapy at 12 weeks (time frame: 12 weeks). 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 2 Feb 2024.