Skin LaxityNCT01422538
Ultherapy™ Treatment Following Sculptra® Treatment
A study testing Ulthera® System, Sculptra® and Sculptra® treatment followed by Ultherapy™ treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Ulthera® System, Sculptra® and Sculptra® treatment followed by Ultherapy™ treatment
- 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
- May 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 35 to 60 years.
- Subject in good health.
- Skin laxity in the lower face and neck.
- Grade 1 and 2 on the Knize Scale
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face and neck.
- Excessive skin laxity on the face and neck.
- No scarring in areas to be treated.
- Any open facial wounds or lesions.
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- Acne on the face.
- Patients who have a history with keloid formation or hypertropic scarring
- Patients who have a hypersensitivity to injectable poly-L-lactic acid
- Presence of a metal stent or implant in the facial area to be treated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Read the detailed description
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.
- Conditions
- Skin Laxity
- Being tested
- Ulthera® System, Sculptra®, Sculptra® treatment followed by Ultherapy™ treatment
- Keywords
- Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening, Skin laxity on the face and neck.
- 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® SystemDevice
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin on the lower face.
Sculptra®Drug
Also called Poly-L-Lactic acid fillers
Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.
Sculptra® treatment followed by Ultherapy™ treatmentOther
Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Subjects will receive Ulthera® System alone. Receives: Device: Ulthera® System |
| Group B | Active comparator | Sculptra® only Receives: Drug: Sculptra® |
| Group C | Active comparator | Sculptra® treatment followed by Ultherapy™ treatment Receives: Other: Sculptra® treatment followed by Ultherapy™ treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.
Measured: 90 days post-treatment
Secondary outcomes (4)
Overall Aesthetic Improvement at 90 Days Post-treatment
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
- = Very Much Improved
- = Much Improved
- = Improved
- = No Change
- = Worse "Any Improvement" includes subjects assessed in categories 1-3.
Measured: 90 days post-treatment.
Overall Aesthetic Improvement at 180 Days Post-treatment
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:
- = Very Much Improved
- = Much Improved
- = Improved
- = No Change
- = Worse "Any Improvement" includes subjects assessed in categories 1-3.
Measured: 180 days post-treatment
Subject Satisfaction at 90 Days Post-treatment
Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.
Measured: 90 days post-treatment.
Subject Satisfaction at 180 Days Post-treatment
Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.
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 posted24 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Burns, MD, Principal investigator, EpiCentre Park Lane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422538
- Sponsor's protocol ID
- ULT-113
- Status last verified
- Nov 2017
- First submitted
- 22 Aug 2011
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
- ClinicalTrials.gov ID
- NCT01422538
- Acronym / sponsor ID
- ULT-113
- Conditions
- Skin Laxity
- Keywords
- Ulthera® System, Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening, Skin laxity on the face and neck.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Posted 27 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Detailed description
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ulthera® SystemSubjects will receive Ulthera® System alone. |
| Group B | Active comparator | Drug: Sculptra®Sculptra® only |
| Group C | Active comparator | Other: Sculptra® treatment followed by Ultherapy™ treatmentSculptra® treatment followed by Ultherapy™ treatment |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged 35 to 60 years.
- Subject in good health.
- Skin laxity in the lower face and neck.
- Grade 1 and 2 on the Knize Scale
Key exclusion criteria (10 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face and neck.
- Excessive skin laxity on the face and neck.
- No scarring in areas 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® SystemAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin on the lower face. | Device | Group A |
| Sculptra®Also: Poly-L-Lactic acid fillersInjectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart. | Drug | Group B |
| Sculptra® treatment followed by Ultherapy™ treatmentSculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra. | Other | Group C |
Primary outcome
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
Time frame: 90 days post-treatment
Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.
4 secondary outcomes
Overall Aesthetic Improvement at 90 Days Post-treatment
Time frame: 90 days post-treatment.
Overall Aesthetic Improvement at 180 Days Post-treatment
Time frame: 180 days post-treatment
Subject Satisfaction at 90 Days Post-treatment
Time frame: 90 days post-treatment.
Subject Satisfaction at 180 Days Post-treatment
Time frame: 180 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay Burns, MD principal investigator
EpiCentre Park Lane
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, Sculptra® and Sculptra® treatment followed by Ultherapy™ 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 4 inclusion and 10 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 13 Dec 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?
Yes. Results are posted in the registry (first posted 27 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. (time frame: 90 days 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 13 Dec 2017.