Feasibility Study: Ulthera System for the Treatment of Rosacea

November 21, 2017 updated by: Ulthera, Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V4
        • Cosmedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. Skin tightening procedure within the past year;

    2. 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)
    3. Neurotoxins within the past three months;
    4. Ablative resurfacing laser treatment;
    5. Nonablative, rejuvenative laser or light treatment within the past six months;
    6. Surgical dermabrasion or deep facial peels

  • History of using the following prescription medications:

    1. Accutane or other systemic retinoids within the past six months;
    2. Topical Retinoids within the past two weeks;
    3. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);
    4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A
Ulthera System providing one treatment per cheek
Device: Ulthera System providing one treatment per cheek
Focused ultrasound energy delivered below the surface of the skin per cheek.
Other Names:
  • Ultherapy™
Active Comparator: Group B
Ulthera System providing two treatments per cheek
Device: Ulthera System providing two treatments per cheek
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ultherapy™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control
Time Frame: 90-days post-treatment treatment
As determined by Primary Investigator assessment
90-days post-treatment treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
Participants will be followed for 90-days post treatment #1 (Group A) or post-treatment #2 (Group B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ulthera, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Lupin, M.D., Cosmedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ULT-131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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