Erythematotelangiectatic RosaceaNCT02144181

Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

A study testing Ulthera System Treatment in people with Erythematotelangiectatic Rosacea and Rosacea, run by Ulthera, Inc at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to 88 subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22 subjects), and will receive study treatments based on their assigned treatment group. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Erythematotelangiectatic Rosacea, Rosacea
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: 88 participants
Where: 5 sitesin 2 countries
Study dates: May 2014to Oct 2016
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female, age 18 to 65 years.
Subject in good health.
Clinical diagnosis of Erythematotelangiectatic Rosacea.
Understands and accepts the obligation not to undergo any other elective procedures, i.e., laser and IPL, in the areas to be treated through the follow-up period.
A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 0 (prior to study treatment commencement).
A Patient Self-Assessment (PSA) of erythema score of greater than or equal to 2 at Screening and at Baseline/Day 0 (prior to study treatment commencement).

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Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. After all study treatments are completed, limited acute NSAID use is allowed. A maximum of 2-3 doses, in the 2 weeks prior to study follow-up visits is allowed, if needed.
Willingness to continue using current skin care and topical treatment regimen during the entire study period (1 year).
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, unless deemed medically necessary.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control .
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 (i.e., removal of jewelry and makeup).
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 disease that may affect wound healing.
More than 5 prominent telangiectases (>0.2mm in width, the width of a thick human hair, images will be provided) in the area(s) to be treated, with the exception of the lateral sides of the nose.
Particular forms of rosacea (papulopustular, phymatous, ocular Rosacea, rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, or acute lupus erythematosus.
Presence of three (3) or more facial inflammatory lesions (papules or pustules) of rosacea.
Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
Intense flushing to a few triggers, such as post-menopausal hot flashes or particular food, versus both intense and less intense flushing to several common triggers.

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Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents which have vasodilation as the MOA (e.g., the calcium channel blockers, such as nifedipine).
Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or clinically diagnosed depression (unless on a stable treatment regimen.)
History of post-inflammatory hyperpigmentation.
Severe solar elastosis.
Significant scarring that would interfere with assessing results in areas to be treated.
Open wounds or lesions in the area(s) to be treated.
Acne.
Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
Inability to understand the protocol or to give informed consent.
Microdermabrasion or glycolic acid peels to the treatment areas within four 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.
History of Bell's Palsy or epilepsy
History of diabetes.
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 inpatient 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 five years.
Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
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:
12 months for Hyaluronic acid fillers (e.g.,Restylane)
12 months for Ca Hydroxyapatite fillers (e.g., Radiesse)
24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and 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 Accutane or other systemic retinoids within the past six months;
Topical retinoids within the past two weeks;
Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);
Chronic use of non-steroidal anti-inflammatories (naproxen, ibuprofen, etc.) within the past 4 weeks.
Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements, understanding and signing the informed consent, or affect their ability to accurately complete QOL and subjective improvement assessments.
Use of Mirvaso (topical brimonidine tartrate) within the previous two weeks.
Use of systemic corticosteroid or immunosuppressive drugs.
Use of antipruritics, including antihistamines, within 24 hours of study visits.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

All About Faces
Hummelstown, Pennsylvania, 17036
Skin Specialists, PC
Omaha, Nebraska, 68144
Laser & Cosmetic Center
Virginia Beach, Virginia, 23462
Wilmington Dermatology Center
Wilmington, North Carolina, 28405

Other trials in United States

Canada1 site

Cosmedica Laser Centre
Victoria, British Columbia, V8R 6V4

Other trials in Canada

About this study

Official title: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Signs and Symptoms of Erythematotelangiectatic Rosacea

Read the detailed description

Clinician Erythema Assessment (CEA) and Patient Self-Assessment (PSA) scores, assessing severity of erythema, will be obtained prior to study treatment to confirm subject eligibility. Enrolled subjects will receive up to three dual-depth treatments to affected areas of the midface (cheeks, chin, forehead, glabella and nose) each treatment provided approximately 2 weeks apart. Groups A and B will receive low-density treatment, and Groups C and D receive high-density treatment. Groups A and C will receive 2 treatments. Groups B and D will receive 3 treatments. Protocol amended Sept 2014: Groups A and C will receive 1 treatment; Groups B and D will receive 2 treatments.

Conditions: Erythematotelangiectatic Rosacea, Rosacea
Being tested: Ulthera System Treatment
Keywords: Ulthera® System, Ultherapy® Treatment, Ulthera, Inc.
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 TreatmentDevice
Also called Ultherapy®
Focused ultrasound energy delivered below the surface of the skin

Study groups in NCT02144181
Study group	Role	What they receive
Group A	Active comparator	Subjects will receive two low-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive one low-density Ulthera System Treatment. Receives: Device: Ulthera System Treatment
Group B	Active comparator	Subjects will receive three low-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive two low-density Ulthera System Treatments. Receives: Device: Ulthera System Treatment
Group C	Active comparator	Subjects will receive two high-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive one high-density Ulthera System Treatment. Receives: Device: Ulthera System Treatment
Group D	Active comparator	Subjects will receive three high-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive two high-density Ulthera System Treatments. Receives: Device: Ulthera System Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinician Erythema Assessment at 90 days post-treatment compared to baseline
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 90 days post-treatment completion. Success is defined as 1-grade improvement on CEA scale.
Measured: 90 Days post-treatment

Secondary outcomes (11)

CEA scale at 180 days post-treatment compared to baseline.
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 180 days post-treatment completion.
Measured: 180 Days post-treatment
CEA scale at 365 days post-treatment compared to baseline.
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 365 days post-treatment completion.
Measured: 365 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 90 Days compared to baseline.
Patient Self-Assessment (PSA) of erythema (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) completed at 90 Days post-treatment.
Measured: 90 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 180 Days compared to baseline.
Patient Self-Assessment (PSA) of erythema (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) completed at 180 Days post-treatment.
Measured: 180 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 365 Days compared to baseline.
Patient Self-Assessment (PSA) of erythema (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) completed at 365 Days post-treatment.
Measured: 365 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 90 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 90 Days post-treatment compared to baseline, a 10-question validated questionnaire.
Measured: 90 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 180 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 180 Days post-treatment compared to baseline, a 10-question validated questionnaire.
Measured: 180 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 365 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 365 Days post-treatment compared to baseline, a 10-question validated questionnaire.
Measured: 365 Days post-treatment
Colorimeter at 90 Days post-treatment
Colorimeter at 90 Days post-treatment compared to baseline. An objective evaluation of the intensity of erythema as a measure of redness using a colorimeter.
Measured: 90 Days post-treatment
Colorimeter at 180 Days post-treatment
Colorimeter at 180 Days post-treatment compared to baseline. An objective evaluation of the intensity of erythema as a measure of redness using a colorimeter.
Measured: 180 Days post-treatment
Colorimeter at 365 Days post-treatment
Colorimeter at 365 Days post-treatment compared to baseline. An objective evaluation of the intensity of erythema as a measure of redness using a colorimeter.
Measured: 365 Days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Oct 2016

First posted21 May 2014 (estimated)
Study startMay 2014
Primary completionDec 2015
Study completionOct 2016

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: Single blind
Who is masked: Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02144181
Sponsor's protocol ID: ULT-138
Status last verified: Oct 2016
First submitted: 19 May 2014
Last updated: 31 Jan 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
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The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea
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All Erythematotelangiectatic Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Signs and Symptoms of Erythematotelangiectatic Rosacea
ClinicalTrials.gov ID: NCT02144181
Acronym / sponsor ID: ULT-138
Conditions: Erythematotelangiectatic Rosacea, Rosacea
Keywords: Ulthera® System, Ultherapy® Treatment, Ulthera, Inc.
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Dec 2015 (actual)
Study completion: Oct 2016 (actual)
First posted: 21 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group A	Active comparator	Device: Ulthera System TreatmentSubjects will receive two low-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive one low-density Ulthera System Treatment.
Group B	Active comparator	Device: Ulthera System TreatmentSubjects will receive three low-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive two low-density Ulthera System Treatments.
Group C	Active comparator	Device: Ulthera System TreatmentSubjects will receive two high-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive one high-density Ulthera System Treatment.
Group D	Active comparator	Device: Ulthera System TreatmentSubjects will receive three high-density Ulthera System Treatments. Protocol amended Sept 2014: Subjects will receive two high-density Ulthera System Treatments.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male or female, age 18 to 65 years.
Subject in good health.
Clinical diagnosis of Erythematotelangiectatic Rosacea.
Understands and accepts the obligation not to undergo any other elective procedures, i.e., laser and IPL, in the areas to be treated through the follow-up period.
A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 0 (prior to study treatment commencement).

Key exclusion criteria (46 listed)

Presence of an active systemic disease that may affect wound healing.
More than 5 prominent telangiectases (>0.2mm in width, the width of a thick human hair, images will be provided) in the area(s) to be treated, with the exception of the lateral sides of the nose.
Particular forms of rosacea (papulopustular, phymatous, ocular Rosacea, rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, or acute lupus erythematosus.
Presence of three (3) or more facial inflammatory lesions (papules or pustules) of rosacea.
Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.

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: Ultherapy®Focused ultrasound energy delivered below the surface of the skin	Device	Group A, Group B, Group C, Group D

Primary outcome

Clinician Erythema Assessment at 90 days post-treatment compared to baseline
Time frame: 90 Days post-treatment
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 90 days post-treatment completion. Success is defined as 1-grade improvement on CEA scale.

11 secondary outcomes

CEA scale at 180 days post-treatment compared to baseline.
Time frame: 180 Days post-treatment
CEA scale at 365 days post-treatment compared to baseline.
Time frame: 365 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 90 Days compared to baseline.
Time frame: 90 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 180 Days compared to baseline.
Time frame: 180 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 365 Days compared to baseline.
Time frame: 365 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 90 Days post-treatment
Time frame: 90 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 180 Days post-treatment
Time frame: 180 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 365 Days post-treatment
Time frame: 365 Days post-treatment
Colorimeter at 90 Days post-treatment
Time frame: 90 Days post-treatment
Colorimeter at 180 Days post-treatment
Time frame: 180 Days post-treatment
Colorimeter at 365 Days post-treatment
Time frame: 365 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 31 Jan 2018.

Related trials for Erythematotelangiectatic Rosacea

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Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
Recruiting
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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, MD principal investigator

Cosmedica Laser Centre

5 sites in 2 countries: 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 Erythematotelangiectatic Rosacea and Rosacea, run by Ulthera, Inc at 5 sites in 2 countries.

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 13 inclusion and 46 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, 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?

Clinician Erythema Assessment at 90 days post-treatment compared to baseline (time frame: 90 Days post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144181.

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 31 Jan 2018.