Acne ScarsNCT02145364
Ultherapy® for the Treatment of Acne Scars
A study testing Ultherapy® treatment in people with Acne Scars and Atrophic Acne Scars, run by Ulthera, Inc at 2 sites in United States.
Trial summary
This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20 subjects will receive study treatments. Following study treatments, follow-up visits will occur at 60, 90 and 180 days from each subject's last study treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acne Scars, Atrophic Acne Scars
- What is being tested?
- Ultherapy® treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 70 years.
- Subject in good health.
- Presence of moderate to severe atrophic acne scars on the cheeks and/or temples.
- Scars must be rolling and boxcar type scars predominantly, with few to no icepick scars present.
- Scars should be distensible with tension applied to skin.
- Subject must desire correction of his/her acne scarring as demonstrated by any level of dissatisfaction on baseline PSQ.
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- Subjects of all Fitzpatrick skin types are eligible.
- Subject must be willing to withhold additional aesthetic therapies in the areas to be treated for the entire study duration if these treatments are judged by the investigator to potentially impact results.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits
- Willingness to maintain current skin care regimen and refrain from adding any new products or drugs for acne or acne scars 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.
- 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.
- Severe solar elastosis.
- Recent history of significant trauma to the face (<6 months).
- Significant scarring, other than acne scars in area(s) to be treated.
- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic active and clinically significant acne on the area(s) to be treated.
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- Have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas.
- Have a history of systemic granulomatous diseases active or inactive or connective tissue disease.
- Have hypertrophic acne scars, any evidence of keloid scarring, predominantly icepick scarring (defined as more than half of all scar area in either the left or right or treatment area) or sinus tract scars.
- Presence of a metal stent or implant in the area(s) to be treated.
- Inability to understand protocol or give informed consent.
- Microdermabrasion or glycolic acid peels to the treatment area(s) within four weeks prior to study participation or during the study.
- History of allergic reaction to Ibuprofen, Acetaminophen, or Lidocaine/Tetracaine.
- 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, or participated within the past 30 days, in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last two years.
- History of the following cosmetic treatments in the areas to be treated:
- Skin tightening procedure within the past year;
- Injectable filler of any type within the past: i. 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. Cultured fibroblast (e.g. LaViv) within the past two years; v. Ever for permanent fillers (e.g., Silicone, ArteFill)
- Neurotoxins within the past three months;
- Ablative resurfacing laser treatment within the past two years;
- Nonablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion or deep facial peels within the past two years;
- 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, chronic NSAID use);
- Aspirin greater than 82mg/day
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent or affect their ability to accurately complete QOL and subjective improvement assessments.
- Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Testing of Beverly Hills
Beverly Hills, California, 90210
The Maas Clinic
San Francisco, California, 94115
About this study
Official title: Evaluation of the Ulthera® System for Correction of Moderate to Severe Atrophic Acne Scars
This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20 subjects will receive study treatments. Following study treatments, follow-up visits will occur at 60, 90 and 180 days from each subject's last study treatment.
Read the detailed description
Subjects with moderate to severe atrophic acne scars will be enrolled. Subjects will receive up to three dual-depth treatments to the cheek and temple areas impacted by acne scars, treating the number of treatment squares necessary to cover the area of scarring. Each treatment square will receive 30 lines per transducer depth for a total of 60 lines per treatment square. Three treatments 30 days apart will be required.
- Conditions
- Acne Scars, Atrophic Acne Scars
- Being tested
- Ultherapy® treatment
- Keywords
- Ulthera System®, Ultherapy®, Ulthera, Inc.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultherapy® treatmentDevice
Also called Ulthera System®
Microfocused ultrasound treatment
| Study group | Role | What they receive |
|---|---|---|
| Ultherapy® treatment of acne scars | Experimental | Subjects receiving dual depth treatment of acne scars using the 7MHz,3.0mm and 10MHz,1.5mm transducers. Receives: Device: Ultherapy® treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Scar Improvement Scale
Determined by a masked, qualitative assessment of photographs at 90 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Measured: 90 Days post-treatment #3
Acne Scar Improvement Scale
Determined by a masked, qualitative assessment of photographs at 180 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Measured: 180 days post-treatment #3
Secondary outcomes (10)
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Determined by PSIS (clinician) assessment and SASIS (subject) assessment at 60 days post final treatment compared to baseline. Clinical improvement will be assessed from the visual assessment of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Measured: 60 days post-treatment #3
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Determined by PSIS (clinician) assessment and SASIS (subject) assessment at 90 days post final treatment compared to baseline. Clinical improvement will be assessed from the visual assessment of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Measured: 90 days post-treatment #3
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Determined by PSIS (clinician) assessment and SASIS (subject) assessment at 180 days post final treatment compared to baseline. Clinical improvement will be assessed from the visual assessment of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Measured: 180 days post-treatment #3
Physician Acne Scar Assessment Scale
Severity of acne scarring is are graded on a 5-point scale (0-4), where 0 = clear, 1= very mild, 2= mild, 3= moderate, 4= severe, comparing the grade assessed at 60 days following the final study treatment to the baseline grade.
Measured: 60 days post-treatment #3
Physician Acne Scar Assessment Scale
Severity of acne scarring is are graded on a 5-point scale (0-4), where 0 = clear, 1= very mild, 2= mild, 3= moderate, 4= severe, comparing the grade assessed at 90 days following the final study treatment to the baseline grade.
Measured: 90 days post-treatment #3
Physician Acne Scar Assessment Scale
Severity of acne scarring is are graded on a 5-point scale (0-4), where 0 = clear, 1= very mild, 2= mild, 3= moderate, 4= severe, comparing the grade assessed at 180 days following the final study treatment to the baseline grade.
Measured: 180 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Overall aesthetic improvement assessed based on a live assessment of the subject and a photographic assessment comparing 60 day post-treatment photos to baseline photos. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
Measured: 60 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Overall aesthetic improvement assessed based on a live assessment of the subject and a photographic assessment comparing 90 day post-treatment photos to baseline photos. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
Measured: 90 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Overall aesthetic improvement assessed based on a live assessment of the subject and a photographic assessment comparing 180 day post-treatment photos to baseline photos. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
Measured: 180 days post-treatment #3
Patient Satisfaction Questionnaire (PSQ)
Patient satisfaction determined by scores on a PSQ completed at 90 days post-treatment #3, indicating improvement in the areas treated and characterizing satisfaction with study treatment, i.e., Extremely Satisfied, Satisfied, Slightly Satisfied, Neither Satisfied or Dissatisfied, Slightly Dissatisfied, Dissatisfied, Extremely Dissatisfied.
Measured: 90 days post-treatment #3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Joseph, MD, Principal investigator, Clinical Testing of Beverly HillsCorey Maas, MD, Principal investigator, The Maas Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145364
- Sponsor's protocol ID
- ULT-139
- Status last verified
- Oct 2015
- First submitted
- 20 May 2014
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ulthera® System for Correction of Moderate to Severe Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT02145364
- Acronym / sponsor ID
- ULT-139
- Conditions
- Acne Scars, Atrophic Acne Scars
- Keywords
- Ulthera System®, Ultherapy®, Ulthera, Inc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 May 2014 (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 a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20 subjects will receive study treatments. Following study treatments, follow-up visits will occur at 60, 90 and 180 days from each subject's last study treatment.
Detailed description
Subjects with moderate to severe atrophic acne scars will be enrolled. Subjects will receive up to three dual-depth treatments to the cheek and temple areas impacted by acne scars, treating the number of treatment squares necessary to cover the area of scarring. Each treatment square will receive 30 lines per transducer depth for a total of 60 lines per treatment square. Three treatments 30 days apart will be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultherapy® treatment of acne scars | Experimental | Device: Ultherapy® treatmentSubjects receiving dual depth treatment of acne scars using the 7MHz,3.0mm and 10MHz,1.5mm transducers. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, age 18 to 70 years.
- Subject in good health.
- Presence of moderate to severe atrophic acne scars on the cheeks and/or temples.
- Scars must be rolling and boxcar type scars predominantly, with few to no icepick scars present.
- Scars should be distensible with tension applied to skin.
Key exclusion criteria (35 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Recent history of significant trauma to the face (<6 months).
- Significant scarring, other than acne scars in area(s) to be treated.
- Open wounds or lesions 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 |
|---|---|---|
| Ultherapy® treatmentAlso: Ulthera System®Microfocused ultrasound treatment | Device | Ultherapy® treatment of acne scars |
Primary outcome
Acne Scar Improvement Scale
Time frame: 90 Days post-treatment #3
Determined by a masked, qualitative assessment of photographs at 90 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Acne Scar Improvement Scale
Time frame: 180 days post-treatment #3
Determined by a masked, qualitative assessment of photographs at 180 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
10 secondary outcomes
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Time frame: 60 days post-treatment #3
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Time frame: 90 days post-treatment #3
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Time frame: 180 days post-treatment #3
Physician Acne Scar Assessment Scale
Time frame: 60 days post-treatment #3
Physician Acne Scar Assessment Scale
Time frame: 90 days post-treatment #3
Physician Acne Scar Assessment Scale
Time frame: 180 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: 60 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: 90 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: 180 days post-treatment #3
Patient Satisfaction Questionnaire (PSQ)
Time frame: 90 days post-treatment #3
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 14 Dec 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.
John Joseph, MD principal investigator
Clinical Testing of Beverly Hills
Corey Maas, MD principal investigator
The Maas Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultherapy® treatment in people with Acne Scars and Atrophic Acne Scars, run by Ulthera, Inc at 2 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 14 inclusion and 35 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 14 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 2 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 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?
Acne Scar Improvement Scale (time frame: 90 Days post-treatment #3). 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 14 Dec 2017.