Skin LaxityNCT01713985
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
A study testing Ulthera System Treatment and Thermage in people with Skin Laxity and Wrinkles, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. 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, Wrinkles
- What is being tested?
- Ulthera System Treatment and Thermage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 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.
- Subject in good health.
- Skin laxity on the area(s) to be treated.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- 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.
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 area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) to be treated.
- Open wounds or lesions in the area(s) to be treated.
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- Severe or cystic acne on the area(s) to be treated.
- Presence of a metal stent or implant in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
- Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- BMI equal to or greater than 25.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck
Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Read the detailed description
This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.
- Conditions
- Skin Laxity, Wrinkles
- Being tested
- Ulthera System Treatment, Thermage
- 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
ThermageDevice
Radiofrequency treatment focusing radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Ulthera System Treatment Right, Thermage Left Receives: Device: Ulthera System Treatment; Device: Thermage |
| Group B | Active comparator | Ulthera System Treatment Left, Thermage Right Receives: Device: Ulthera System Treatment; Device: Thermage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Lifting and Tightening of Skin
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
Measured: 180 days post treatment
Number of Participants with Wrinkle Reduction
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
Measured: 180 days post treatment
Secondary outcomes (3)
Number of Participants with Eyebrow Lift
Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.
Measured: 90 days post-treatment
Number of Participants with Lower face and Neck Lift
Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.
Measured: 90 days post-treatment
Number of Participants Reporting Treatment Satisfaction
Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.
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 posted25 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Cohen, MD, Principal investigator, Faces+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713985
- Sponsor's protocol ID
- ULT-135
- Status last verified
- Sep 2013
- First submitted
- 15 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: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck
- ClinicalTrials.gov ID
- NCT01713985
- Acronym / sponsor ID
- ULT-135
- Conditions
- Skin Laxity, Wrinkles
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 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 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed description
This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ulthera System Treatment, Device: ThermageUlthera System Treatment Right, Thermage Left |
| Group B | Active comparator | Device: Ulthera System Treatment, Device: ThermageUlthera System Treatment Left, Thermage Right |
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.
- Subject in good health.
- Skin laxity on the area(s) to be treated.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- 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.
Key exclusion criteria (12 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) 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 System TreatmentAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Device | Group A, Group B |
| ThermageRadiofrequency treatment focusing radiofrequency energy | Device | Group A, Group B |
Primary outcome
Number of Participants with Lifting and Tightening of Skin
Time frame: 180 days post treatment
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
Number of Participants with Wrinkle Reduction
Time frame: 180 days post treatment
Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
3 secondary outcomes
Number of Participants with Eyebrow Lift
Time frame: 90 days post-treatment
Number of Participants with Lower face and Neck Lift
Time frame: 90 days post-treatment
Number of Participants Reporting Treatment Satisfaction
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 Cohen, MD principal investigator
Faces+
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 and Thermage in people with Skin Laxity and Wrinkles, 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 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 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?
Number of Participants with Lifting and Tightening of Skin (time frame: 180 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.