Peri-orbital WrinklesNCT01981252
Peri-orbital and Peri-oral Wrinkle Reduction Trial
A study testing Ulthera® System Treatment in people with Peri-orbital Wrinkles and Peri-oral Wrinkles, run by Ulthera, Inc at 5 sites in United States.
Trial summary
This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-orbital Wrinkles, Peri-oral Wrinkles
- What is being tested?
- Ulthera® System Treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2013to Aug 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 30 to 75 years.
- Subject in good health.
- BMI<25
- Fitzpatrick wrinkle score of 3-7 in the peri-orbital and peri-oral areas.
- Moderate skin laxity in the peri-orbital area contributing to rhytids as assessed by the investigator.
- Understands and accepts the obligation not to undergo any other procedures, including neurotoxin and filler treatments, on the face through the follow-up period.
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- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment.
- Willingness and ability to continue with their current daily skin care routine, with the exception of any use of products containing glycolic acid, for the duration of the study.
- 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 the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- BMI equal to or greater than 25
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Mild or severe skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) to be treated.
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- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic acne on the area(s) to be treated.
- Active implantables (e.g., pacemakers or defibrillators) or metallic implants in the treatment area.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 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.
- History of chronic drug or alcohol abuse.
- History of autoimmune disease.
- History of Bell's Palsy or epilepsy.
- History of diabetes.
- Has a known allergy, or a known history of sensitivity, to lidocaine, tetracaine, para-aminobenzoic acid (PABA).
- Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last five years.
- History of the following cosmetic treatments in the area(s) to be treated:
- Skin tightening procedure within the past year;
- Injectable fillers of any type within the past 12 or 24 months, depending on type;
- Neurotoxins within the past six months;
- Ablative resurfacing laser treatment;
- Nonablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion or deep facial peels;
- Facelift, blepharoplasty, or browlift within the past 2 years; or
- Any history of contour threads.
- History of using the following prescription medications:
- Accutane or other systemic retinoids within the past six months;
- Topical Retinoids within the past four weeks;
- Antiplatelet agents/Anticoagulants;
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Advanced Facial Plastic Surgery
Beverly Hills, California, 90212
Dermatology Research Institute
Coral Gables, Florida, 33146
About Skin Dermatology and DermSurgery, PC
Englewood, Colorado, 80113
Aesthetic Plastic Surgical Institute
Laguna Beach, California, 92651
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203
About this study
Official title: Evaluation of the Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions
This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
- Conditions
- Peri-orbital Wrinkles, Peri-oral Wrinkles
- Being tested
- Ulthera® System Treatment
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)
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® System Treatment | Experimental | Ulthera® System treatment of the peri-orbital and peri-oral regions. Receives: Device: Ulthera® System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2.
Measured: Participants will be followed to 90 days post-treatment #2
Secondary outcomes (6)
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2.
Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 180 days post-treatment #2.
Measured: Participants will be followed to 180 days post-treatment #2
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2.
Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 90 days post-treatment #2.
Measured: Participants will be followed to 90 days post-treatment #2
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2.
Quantitative wrinkle depth measurements will be performed using a 3-D imaging system at 180 days post-treatment #2.
Measured: Participants will be followed to 180 days post-treatment #2
Overall Aesthetic Improvement
Overall aesthetic improvement at 90 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS).
Measured: Participants will be followed to 90 days post-treatment #2
Overall Aesthetic Improvement
Overall aesthetic improvement at 180 days post treatment #2 compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS).
Measured: Participants will be followed to 180 days post-treatment #2
Subject Satisfaction
Subject satisfaction will be measured at using a Patient Satisfaction Questionnaire.
Measured: Participants will be followed to 90 days post-treatment #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-orbital 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Biesman, MD, Principal investigator, Nashville Centre for Laser and Facial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981252
- Sponsor's protocol ID
- ULT-137
- Status last verified
- Oct 2014
- First submitted
- 4 Nov 2013
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 Safety and Efficacy of the Ulthera® System for Wrinkle Reduction in the Peri-orbital and Peri-oral Regions
- ClinicalTrials.gov ID
- NCT01981252
- Acronym / sponsor ID
- ULT-137
- Conditions
- Peri-orbital Wrinkles, Peri-oral Wrinkles
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Nov 2013 (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.
This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulthera® System Treatment | Experimental | Device: Ulthera® System TreatmentUlthera® System treatment of the peri-orbital and peri-oral regions. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, age 30 to 75 years.
- Subject in good health.
- BMI<25
- Fitzpatrick wrinkle score of 3-7 in the peri-orbital and peri-oral areas.
- Moderate skin laxity in the peri-orbital area contributing to rhytids as assessed by the investigator.
Key exclusion criteria (36 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- BMI equal to or greater than 25
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Mild or severe skin laxity on 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 | Ulthera® System Treatment |
Primary outcome
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2.
Time frame: Participants will be followed to 90 days post-treatment #2
Assessment of improvement, in a blinded fashion, using the Fitzpatrick Wrinkle Scale at 90 days post-treatment #2.
6 secondary outcomes
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 180 days Post Treatment #2.
Time frame: Participants will be followed to 180 days post-treatment #2
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 90 days post treatment #2.
Time frame: Participants will be followed to 90 days post-treatment #2
Number of participants with a reduction in peri-orbital and/or peri-oral wrinkle depth at 180 days Post Treatment #2.
Time frame: Participants will be followed to 180 days post-treatment #2
Overall Aesthetic Improvement
Time frame: Participants will be followed to 90 days post-treatment #2
Overall Aesthetic Improvement
Time frame: Participants will be followed to 180 days post-treatment #2
Subject Satisfaction
Time frame: Participants will be followed to 90 days post-treatment #2
Results and safety
The study was stopped early (reason given: Lack of efficacy.). 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.
Brian Biesman, MD principal investigator
Nashville Centre for Laser and Facial Surgery
5 sites 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 Peri-orbital Wrinkles and Peri-oral Wrinkles, run by Ulthera, Inc at 5 sites 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 13 inclusion and 36 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 5 sites 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: Lack of efficacy.). 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?
Number of participants with reduction in peri-orbital and/or peri-oral wrinkles at 90 days post-treatment #2. (time frame: Participants will be followed to 90 days post-treatment #2). 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.