Erythematotelangiectatic RosaceaNCT01756027
Feasibility Study: Ulthera System for the Treatment of Rosacea
A study testing Ulthera System providing one treatment per cheek and Ulthera System providing two treatments per cheek in people with Erythematotelangiectatic Rosacea, run by Ulthera, Inc at 1 site in Canada.
Trial summary
Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erythematotelangiectatic Rosacea
- What is being tested?
- Ulthera System providing one treatment per cheek and Ulthera System providing two treatments per cheek
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Oct 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 years.
- Subject in good health.
- Clinical diagnosis of Erythematotelangiectatic Rosacea.
- Understands and accepts the obligation not to undergo any other procedures in the area(s) 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.
- Absence of physical or psychological conditions unacceptable to the investigator.
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- Willingness and ability to provide written consent for study-required photography and adherence to photography requirements.
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1.
Who cannot join
- Presence of an active systemic disease that may affect wound healing.
- Prominent telangiectases in the area(s) to be treated.
- History of post-inflammatory hyperpigmentation.
- Papulopustular or Phymatous Rosacea.
- Severe solar elastosis.
- Significant scarring in 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.
- Presence of a metal stent or implant in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within six 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.
- 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 five years.
- History of the following cosmetic 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)
- 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse)
- 24 months for Poly-L-Lactic acid fillers (e.g., Sculptra)
- Ever for permanent fillers (e.g., Silicone, ArteFill)
- Neurotoxins within the past three months;
- Ablative resurfacing laser treatment;
- Nonablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion or deep facial peels
- 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);
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study: Evaluation of the Effectiveness and Safety of the Ulthera® System for Treatment of Erythematotelangiectatic Rosacea
Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Read the detailed description
This study is a prospective, randomized, single-center clinical trial. The study will be conducted in two Phases. In Phase I, subjects will be assigned to one of two treatment groups. One study group will receive one dual depth Ultherapy treatment to a region on the cheeks, and one study group will receive two dual depth Ultherapy treatments to a region on the cheeks 14 days apart. Average pain scores will be obtained using a Numeric Rating Scale following each region of treatment and for each depth of treatment. In Phase II, based on observations of last follow-up visit in Phase I (at 90 days after treatment), subjects will be given the option to receive treatment of the affected area(s) for the protocol specified region, treated at the treatment depth showing the most efficacy in Phase I. Efficacy will be determined by improvement in Erythematotelangiectatic Rosacea in the treatment area versus control (an untreated area) as determined by primary investigator assessment at the last follow-up visit in Phase I.
- Conditions
- Erythematotelangiectatic Rosacea
- Being tested
- Ulthera System providing one treatment per cheek, Ulthera System providing two treatments per cheek
- Keywords
- Rosacea, Ulthera System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for the skin
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera System providing one treatment per cheekDevice
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin per cheek.
Ulthera System providing two treatments per cheekDevice
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Ulthera System providing one treatment per cheek Receives: Device: Ulthera System providing one treatment per cheek |
| Group B | Active comparator | Ulthera System providing two treatments per cheek Receives: Device: Ulthera System providing two treatments per cheek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control
As determined by Primary Investigator assessment
Measured: 90-days post-treatment treatment
Secondary outcomes (1)
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control (untreated area)
As determined by a live patient assessment and investigator designation of improved versus not improved for the area treated compared to the surrounding area at follow-up in Phase I
Measured: Participants will be followed for 90-days post treatment #1 (Group A) or post-treatment #2 (Group B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematotelangiectatic RosaceaStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Lupin, M.D., Principal investigator, Cosmedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756027
- Sponsor's protocol ID
- ULT-131
- Status last verified
- Nov 2013
- First submitted
- 19 Dec 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 Effectiveness and Safety of the Ulthera® System for Treatment of Erythematotelangiectatic Rosacea
- ClinicalTrials.gov ID
- NCT01756027
- Acronym / sponsor ID
- ULT-131
- Conditions
- Erythematotelangiectatic Rosacea
- Keywords
- Rosacea, Ulthera System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for the skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Dec 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 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Detailed description
This study is a prospective, randomized, single-center clinical trial. The study will be conducted in two Phases. In Phase I, subjects will be assigned to one of two treatment groups. One study group will receive one dual depth Ultherapy treatment to a region on the cheeks, and one study group will receive two dual depth Ultherapy treatments to a region on the cheeks 14 days apart. Average pain scores will be obtained using a Numeric Rating Scale following each region of treatment and for each depth of treatment. In Phase II, based on observations of last follow-up visit in Phase I (at 90 days after treatment), subjects will be given the option to receive treatment of the affected area(s) for the protocol specified region, treated at the treatment depth showing the most efficacy in Phase I. Efficacy will be determined by improvement in Erythematotelangiectatic Rosacea in the treatment area versus control (an untreated area) as determined by primary investigator assessment at the last follow-up visit in Phase I.
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 providing one treatment per cheekUlthera System providing one treatment per cheek |
| Group B | Active comparator | Device: Ulthera System providing two treatments per cheekUlthera System providing two treatments per cheek |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, aged 18 to 65 years.
- Subject in good health.
- Clinical diagnosis of Erythematotelangiectatic Rosacea.
- Understands and accepts the obligation not to undergo any other procedures in the area(s) 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 (35 listed)
- Presence of an active systemic disease that may affect wound healing.
- Prominent telangiectases in the area(s) to be treated.
- History of post-inflammatory hyperpigmentation.
- Papulopustular or Phymatous Rosacea.
- Severe solar elastosis.
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 providing one treatment per cheekAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin per cheek. | Device | Group A |
| Ulthera System providing two treatments per cheekAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Device | Group B |
Primary outcome
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control
Time frame: 90-days post-treatment treatment
As determined by Primary Investigator assessment
1 secondary outcome
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control (untreated area)
Time frame: Participants will be followed for 90-days post treatment #1 (Group A) or post-treatment #2 (Group B)
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.
Mark Lupin, M.D. principal investigator
Cosmedica
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 System providing one treatment per cheek and Ulthera System providing two treatments per cheek in people with Erythematotelangiectatic Rosacea, run by Ulthera, Inc at 1 site in Canada.
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 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 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 Canada. 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?
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control (time frame: 90-days post-treatment 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.