WrinklesNCT01713907
Evaluation of the Ulthera® System for Treatment of the Face and Neck
A study testing Ulthera® Treatment in people with Wrinkles and Rhytids, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles, Rhytids, 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 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, aged 30 to 65 years.
- Subject in good health.
- Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
- Mild to moderate rhytids in the periorbital or perioral region.
- Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
- Mild to moderate vertical perioral lines
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- Mild to moderate marionette lines.
- Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
- 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 on the cheek.
- Excessive skin laxity on the lower face and neck.
- Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
- Excessive hooding with or without redundant skin in the areas to be treated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, 20852
About this study
Official title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 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, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
- Conditions
- Wrinkles, Rhytids, Skin Laxity
- Being tested
- Ulthera® Treatment
- Keywords
- Ultherapy™ treatment, Ulthera® System, 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™ System, Ulthera, Inc.
Focused ultrasound energy delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Ulthera® treatment | Experimental | All enrolled subjects will receive one full face and neck Ulthera® treatment. Receives: Device: Ulthera® Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in facial wrinkles and lifting and tightening of skin
Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
Measured: 90 days post-treatment
Secondary outcomes (2)
Overall aesthetic improvement
Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.
Measured: Participants will be followed up to 180 days post-treatment
Overall patient satisfaction
Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
Measured: 90 and 180 day 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 startJun 2011
- Primary completionOct 2011
- Study completionJan 2012
Why it stopped: Inadequate study staff to appropriately manage trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hema Sundaram, MD, Principal investigator, Dermatology, Cosmetic & Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713907
- Sponsor's protocol ID
- ULT-109
- Status last verified
- Feb 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
- Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity
- ClinicalTrials.gov ID
- NCT01713907
- Acronym / sponsor ID
- ULT-109
- Conditions
- Wrinkles, Rhytids, Skin Laxity
- Keywords
- Ultherapy™ treatment, Ulthera® System, Ulthera, Inc., Ultrasound treatment for skin tightening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate study staff to appropriately manage trial.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (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 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 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, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve jawline definition and submental skin laxity. Changes from baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life 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 | Experimental | Device: Ulthera® TreatmentAll enrolled subjects will receive one full face and neck Ulthera® treatment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged 30 to 65 years.
- Subject in good health.
- Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
- Mild to moderate rhytids in the periorbital or perioral region.
- Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
Key exclusion criteria (6 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheek.
- Excessive skin laxity on the lower face and neck.
- Deep wrinkles, numerous lines, with or without redundant skin in the 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® TreatmentAlso: Ultherapy™ System, Ulthera, Inc.Focused ultrasound energy delivered below the surface of the skin. | Device | Ulthera® treatment |
Primary outcome
Improvement in facial wrinkles and lifting and tightening of skin
Time frame: 90 days post-treatment
Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
2 secondary outcomes
Overall aesthetic improvement
Time frame: Participants will be followed up to 180 days post-treatment
Overall patient satisfaction
Time frame: 90 and 180 day post-treatment
Results and safety
The study was stopped early (reason given: Inadequate study staff to appropriately manage trial.). 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.
Hema Sundaram, MD principal investigator
Dermatology, Cosmetic & Laser Surgery
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 Wrinkles and Rhytids, 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 10 inclusion and 6 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: Inadequate study staff to appropriately manage trial.). 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?
Improvement in facial wrinkles and lifting and tightening of skin (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 24 Nov 2017.