Facial AcneNCT01591304
Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne
A study testing Ulthera System Treatment in people with Facial Acne, run by Ulthera, Inc at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Acne
- What is being tested?
- Ulthera System Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 years and older.
- Subject in good health.
- Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.
Who cannot join
- Presence of >2 nodular lesions in the areas to be treated.
- Presence of any cysts in the areas to be treated.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.
- History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
- History of keloid scar formation.
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- Significant scarring in areas to be treated.
- Significant open facial wounds or lesions.
- Presence of a metal stent or implant in the facial area to be treated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Multispecialty Aesthetic Clinical Research Organization
Woodland Hills, California, 91367
About this study
Official title: Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne
This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.
Read the detailed description
Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.
- For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
- For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.
Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.
- Conditions
- Facial Acne
- Being tested
- Ulthera System Treatment
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera System TreatmentDevice
Also called Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
Focused ultrasound energy delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively. Receives: Device: Ulthera System Treatment |
| Group B | Active comparator | Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively. Receives: Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in facial acne
Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.
Measured: 60 days post-treatment
Secondary outcomes (4)
Change from baseline in skin clarity
Measured using a digital imaging system comparing baseline and post-treatment images.
Measured: 180 days post-treatment
Reduction of sebum production
Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.
Measured: 180 days post-treatment
Patient Satisfaction at 60 days
Patient satisfaction as determined by completion of a patient satisfaction questionnaire.
Measured: 60 day post-treatment
Patient Satisfaction at 180 days
Patient satisfaction as determined by completion of patient satisfaction questionnaire.
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 posted3 May 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AcneStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Girish Munavalli, M.D., Principal investigator, Dermatology, Laser & Vein Specialists of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591304
- Sponsor's protocol ID
- ULT-116
- Status last verified
- Dec 2014
- First submitted
- 27 Apr 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 Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne
- ClinicalTrials.gov ID
- NCT01591304
- Acronym / sponsor ID
- ULT-116
- Conditions
- Facial Acne
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 May 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.
This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.
Detailed description
Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.
- For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
- For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.
Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ulthera System TreatmentUlthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively. |
| Group B | Active comparator | Device: Ulthera System TreatmentUlthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 18 years and older.
- Subject in good health.
- Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.
Key exclusion criteria (9 listed)
- Presence of >2 nodular lesions in the areas to be treated.
- Presence of any cysts in the areas to be treated.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.
- History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
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: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.Focused ultrasound energy delivered below the surface of the skin. | Device | Group A, Group B |
Primary outcome
Change from baseline in facial acne
Time frame: 60 days post-treatment
Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.
4 secondary outcomes
Change from baseline in skin clarity
Time frame: 180 days post-treatment
Reduction of sebum production
Time frame: 180 days post-treatment
Patient Satisfaction at 60 days
Time frame: 60 day post-treatment
Patient Satisfaction at 180 days
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.
Girish Munavalli, M.D. principal investigator
Dermatology, Laser & Vein Specialists of the Carolinas
2 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 Facial Acne, 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 3 inclusion and 9 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 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?
Change from baseline in facial acne (time frame: 60 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.