Skin LaxityNCT01708252
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
A study testing Ulthera System Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. 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 System Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2012
- 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.
- Subject in good health.
- BMI < 30.
- Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
- Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.
Who cannot join
- Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheeks.
- Excessive skin laxity on the lower face and neck
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Read the detailed description
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
- Conditions
- Skin Laxity
- Being tested
- Ulthera System 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 System TreatmentDevice
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Ulthera treatment group | Experimental | All subjects will receive an Ulthera System Treatment Receives: Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in lower face and neck skin laxity
Efficacy will be assessed using the 90-day images compared to baseline
Measured: 90 days post-treatment
Cervicomental angle
Efficacy will be assessed using the 90-day images compared to baseline.
Measured: 90 days post-treatment
Secondary outcomes (5)
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
Measured: 90 days post-treatment
Patient satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
Measured: 90 days post-treatment
Pain Assessment
Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
Measured: Treatment visit
Patient Satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
Measured: 180 days post-treatment
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
Measured: 180 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionAug 2012
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven H Dayan, MD, FACS, Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708252
- Sponsor's protocol ID
- ULT-127
- Status last verified
- Jun 2013
- First submitted
- 7 Nov 2011
- 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: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment
- ClinicalTrials.gov ID
- NCT01708252
- Acronym / sponsor ID
- ULT-127
- Conditions
- Skin Laxity
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 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 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Detailed description
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulthera treatment group | Experimental | Device: Ulthera System TreatmentAll subjects will receive an Ulthera System Treatment |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age 30 to 65 years.
- Subject in good health.
- BMI < 30.
- Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
Key exclusion criteria (8 listed)
- Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheeks.
- Excessive skin laxity on the lower face and neck
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 System TreatmentAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Device | Ulthera treatment group |
Primary outcome
Improvement in lower face and neck skin laxity
Time frame: 90 days post-treatment
Efficacy will be assessed using the 90-day images compared to baseline
Cervicomental angle
Time frame: 90 days post-treatment
Efficacy will be assessed using the 90-day images compared to baseline.
5 secondary outcomes
Overall aesthetic improvement
Time frame: 90 days post-treatment
Patient satisfaction
Time frame: 90 days post-treatment
Pain Assessment
Time frame: Treatment visit
Patient Satisfaction
Time frame: 180 days post-treatment
Overall aesthetic improvement
Time frame: 180 days post-treatment
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 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.
Steven H Dayan, MD, FACS principal investigator
DeNova Research
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 System 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 6 inclusion and 8 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 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 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?
Improvement in lower face and neck skin laxity (time frame: 90 days post-treatment). The study lists 2 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 24 Nov 2017.