Skin LaxityNCT01713569
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
A study testing Ulthera Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Ulthera Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2013
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 30 to 65 years scheduled for rhytidectomy.
- Subject in good health.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated.
- Presence of a metal stent or implant in the facial area to be treated.
- Inability to understand the protocol or to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, 91105
About this study
Official title: Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System
Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.
Read the detailed description
This study is a prospective, single-center clinical trial. Subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent. Enrolled subjects will be treated with an assigned transducer based on their order of enrollment. At the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure.
- Conditions
- Skin Laxity
- Being tested
- Ulthera Treatment
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera TreatmentDevice
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Subject 1 | Active comparator | Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 1.2 Joules and 30 Watts on the Left side versus 0.9 Joules and 30 Watts on the Right side. Receives: Device: Ulthera Treatment |
| Subject 2 | Active comparator | Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 1.05 Joules and 25 Watts on the Left side versus 0.75 Joules and 25 Watts on the Right side. Receives: Device: Ulthera Treatment |
| Subject 3 | Active comparator | Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 0.45 Joules and 15 Watts on the Left side versus 0.35 Joules and 14 Watts on the Right side. Receives: Device: Ulthera Treatment |
| Subject 4 | Active comparator | Ulthera treatment will be administered to both pre-auricular regions using a 10 MHz, 1.5mm depth transducer at 0.25 Joules and 5 Watts on the Left side versus 0.18 Joules and 5 Watts on the Right side. Receives: Device: Ulthera Treatment |
| Subject 5 | Active comparator | Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus 7 MHz, 4.5mm 0.9 Joules and 25 Watts on the Right side. Receives: Device: Ulthera Treatment |
| Subject 6 | Active comparator | Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm transducer at 0.35 and 14 Watts, and a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus a 7 MHz, 3.0mm depth and 4.5mm depth transducer at 2.0 Joules and 40 Watts on the Right side. Receives: Device: Ulthera Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the depth of focused thermal injury and thermal injury zone dimensions.
Post-treatment, treated tissue will be resected for histological analysis.
Measured: 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionOct 2013
Why it stopped: Slow subject enrollment; study to be obtained is no longer required.
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon Sasaki, MD, Principal investigator, Sasaki Advanced Aesthetic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713569
- Sponsor's protocol ID
- ULT-122
- Status last verified
- Nov 2013
- First submitted
- 22 Oct 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System
- ClinicalTrials.gov ID
- NCT01713569
- Acronym / sponsor ID
- ULT-122
- Conditions
- Skin Laxity
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow subject enrollment; study to be obtained is no longer required.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Oct 2012 (estimated)
- 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.
Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.
Detailed description
This study is a prospective, single-center clinical trial. Subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent. Enrolled subjects will be treated with an assigned transducer based on their order of enrollment. At the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subject 1 | Active comparator | Device: Ulthera TreatmentUlthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 1.2 Joules and 30 Watts on the Left side versus 0.9 Joules and 30 Watts on the Right side. |
| Subject 2 | Active comparator | Device: Ulthera TreatmentUlthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 1.05 Joules and 25 Watts on the Left side versus 0.75 Joules and 25 Watts on the Right side. |
| Subject 3 | Active comparator | Device: Ulthera TreatmentUlthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 0.45 Joules and 15 Watts on the Left side versus 0.35 Joules and 14 Watts on the Right side. |
| Subject 4 | Active comparator | Device: Ulthera TreatmentUlthera treatment will be administered to both pre-auricular regions using a 10 MHz, 1.5mm depth transducer at 0.25 Joules and 5 Watts on the Left side versus 0.18 Joules and 5 Watts on the Right side. |
| Subject 5 | Active comparator | Device: Ulthera TreatmentUlthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus 7 MHz, 4.5mm 0.9 Joules and 25 Watts on the Right side. |
| Subject 6 | Active comparator | Device: Ulthera TreatmentUlthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm transducer at 0.35 and 14 Watts, and a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus a 7 MHz, 3.0mm depth and 4.5mm depth transducer at 2.0 Joules and 40 Watts on the Right side. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age 30 to 65 years scheduled for rhytidectomy.
- Subject in good health.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
Key exclusion criteria (7 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated.
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 |
|---|---|---|
| Ulthera TreatmentAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Device | Subject 1, Subject 2, Subject 3, Subject 4, Subject 5, Subject 6 |
Primary outcome
To determine the depth of focused thermal injury and thermal injury zone dimensions.
Time frame: 48 hours post-treatment
Post-treatment, treated tissue will be resected for histological analysis.
Results and safety
The study was stopped early (reason given: Slow subject enrollment; study to be obtained is no longer required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
Gordon Sasaki, MD principal investigator
Sasaki Advanced Aesthetic Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera Treatment in people with Skin Laxity, run by Ulthera, 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Nov 2017. 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?
The study was stopped early (reason given: Slow subject enrollment; study to be obtained is no longer required.). Results are not available in the source record.
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?
To determine the depth of focused thermal injury and thermal injury zone dimensions. (time frame: 48 hours post-treatment). 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 24 Nov 2017.