Surgical ScarNCT01883414
Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.
A study testing Ultherapy™ in people with Surgical Scar, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after treatment. Study images will be obtained before treatment, immediately after treatment and at each follow-up visit. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Scar
- What is being tested?
- Ultherapy™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 70 years.
- Subject in good health.
- Subjects will have regularly shaped surgical scars on the chest, abdomen or back that are at least 4 cm long, are no wider than 1 cm, and are at least 6 months old.
- 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.
- 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 (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
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- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- Allergy to any pain medications used in the study (lidocaine, NSAIDs, narcotics, etc.)
- Severe solar elastosis.
- Open wounds or lesions in the area(s) to be treated.
- 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.
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- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within three months prior to study participation or during the study.
- Intralesional kenalog in the past 6 months.
- History of chronic drug or alcohol abuse.
- History of autoimmune disease.
- Concurrent 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 year.
- History of the following treatments in the area(s) to be treated:
- Skin tightening procedure within the past year;
- Injectable filler of any type within the past:
- 12 months for Hyaluronic acid fillers (e.g. Restylane) ii. 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse) iii. 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra) iv. Ever for permanent fillers (e.g. Silicone, ArteFill) c. Neurotoxins within the past three months; d. Ablative resurfacing laser treatment; e. Nonablative, rejuvenative laser or light treatment within the past six months; f. Surgical dermabrasion or deep peels; g. 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 two weeks;
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, etc.);
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
- Subjects that are immunocompromised or are on immunosuppressive therapy
- Subjects that are immunocompromised or are on immunosuppressive therapy
- History of keloids
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Dermatology Laser and Cosmetic Center
Boston, Massachusetts, 02114
About this study
Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after treatment. Study images will be obtained before treatment, immediately after 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 the appearance of scar tissue on the neck, abdomen or back. Changes from baseline of the Patient Observer Scar Assessment Scale score will be assessed at study follow-up visits. Images will be obtained prior to treatment and at each follow up visit. Patient satisfaction questionnaires will also be obtained.
- Conditions
- Surgical Scar
- Being tested
- Ultherapy™
- Keywords
- Ulthera, Ultherapy, Surgical scar, scar,
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultherapy™Device
All subjects will receive an Ultherapy™ treatment at triple depth using the 4-4.5mm, 7- 3.0mm, 10-1.5mm transducers on one half of the scar and no treatment on the other half of the scar. Treatments will be provided to the defined scar area, treating with a density of lines that is equivalent to 30 lines per transducer per 2.5cm in scar length for a total of 90 lines in a 2.5cm X 2.5cm square area.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Subjects randomized to Group A will receive Ultherapy™ treatment on the superior or lateral half of the scar. Receives: Device: Ultherapy™ |
| Group B | Active comparator | Subjects randomized to Group B will receive Ultherapy™ treatment on the inferior or medial half of the scar. Receives: Device: Ultherapy™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar.
Masked assessors will compare baseline images to images obtained at the 90 day follow up time point in a blinded fashion.
Measured: 90 days
Secondary outcomes (3)
1. Improvement in POSAS score of the treated half of the scar as assessed by the observer using the Patient and Observer Scar Assessment Scale (POSAS) at 90-days post-treatment compared to baseline.
The observer will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
Measured: 90 Days
2. Difference in POSAS score as assessed by the patient using the Patient Observer Scar Assessment Scale (POSAS) between the treated and untreated half of the scar at 90-days post-treatment compared to baseline.
The subject will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
Measured: 90 Days
3. Patient satisfaction questionnaire at the 90-day follow-up visit.
Each subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 90 follow-up visit. These results will be tabulated to assess subjects satisfaction with the treatment.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Lack of resources to manage trial; lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ScarStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew Avram, MD, Principal investigator, MGH Dermatology, Laser and Cosmetic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883414
- Sponsor's protocol ID
- ULT-136 Avram
- Status last verified
- Mar 2014
- First submitted
- 18 Jun 2013
- 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 Improvement of Surgical Scars.
- ClinicalTrials.gov ID
- NCT01883414
- Acronym / sponsor ID
- ULT-136 Avram
- Conditions
- Surgical Scar
- Keywords
- Ulthera, Ultherapy, Surgical scar, scar,
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources to manage trial; lack of efficacy.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jun 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.
Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after treatment. Study images will be obtained before treatment, immediately after 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 the appearance of scar tissue on the neck, abdomen or back. Changes from baseline of the Patient Observer Scar Assessment Scale score will be assessed at study follow-up visits. Images will be obtained prior to treatment and at each follow up visit. Patient satisfaction questionnaires will also be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ultherapy™Subjects randomized to Group A will receive Ultherapy™ treatment on the superior or lateral half of the scar. |
| Group B | Active comparator | Device: Ultherapy™Subjects randomized to Group B will receive Ultherapy™ treatment on the inferior or medial half of the scar. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age 18 to 70 years.
- Subject in good health.
- Subjects will have regularly shaped surgical scars on the chest, abdomen or back that are at least 4 cm long, are no wider than 1 cm, and are at least 6 months old.
- 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 (28 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Allergy to any pain medications used in the study (lidocaine, NSAIDs, narcotics, etc.)
- Severe solar elastosis.
- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic acne 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 |
|---|---|---|
| Ultherapy™All subjects will receive an Ultherapy™ treatment at triple depth using the 4-4.5mm, 7- 3.0mm, 10-1.5mm transducers on one half of the scar and no treatment on the other half of the scar. Treatments will be provided to the defined scar area, treating with a density of lines that is equivalent to 30 lines per transducer per 2.5cm in scar length for a total of 90 lines in a 2.5cm X 2.5cm square area. | Device | Group A, Group B |
Primary outcome
The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar.
Time frame: 90 days
Masked assessors will compare baseline images to images obtained at the 90 day follow up time point in a blinded fashion.
3 secondary outcomes
1. Improvement in POSAS score of the treated half of the scar as assessed by the observer using the Patient and Observer Scar Assessment Scale (POSAS) at 90-days post-treatment compared to baseline.
Time frame: 90 Days
2. Difference in POSAS score as assessed by the patient using the Patient Observer Scar Assessment Scale (POSAS) between the treated and untreated half of the scar at 90-days post-treatment compared to baseline.
Time frame: 90 Days
3. Patient satisfaction questionnaire at the 90-day follow-up visit.
Time frame: 90 Days
Results and safety
The study was stopped early (reason given: Lack of resources to manage trial; 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.
Mathew Avram, MD principal investigator
MGH Dermatology, Laser and Cosmetic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultherapy™ in people with Surgical Scar, 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 9 inclusion and 28 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: Lack of resources to manage trial; 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?
The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar. (time frame: 90 days). 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.