Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

NCT02144181 | Completed DMC

• 1 other identifier: ULT-138
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 5

Brief 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. Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each subject's last study treatment.

Conditions

Erythematotelangiectatic Rosacea; Rosacea

Keywords

Ulthera® System; Ultherapy® Treatment; Ulthera, Inc.

Outcome Measures

Primary Outcomes (1)

• 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.

  90 Days post-treatment

Secondary Outcomes (11)

• CEA scale at 180 days post-treatment compared to baseline.

  180 Days post-treatment

• CEA scale at 365 days post-treatment compared to baseline.

  365 Days post-treatment

• Patient Self-Assessment (PSA) of erythema at 90 Days compared to baseline.

  90 Days post-treatment

• Patient Self-Assessment (PSA) of erythema at 180 Days compared to baseline.

  180 Days post-treatment

• Patient Self-Assessment (PSA) of erythema at 365 Days compared to baseline.

  365 Days post-treatment

Study Arms (4)

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.

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.

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.

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.

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy®

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (5)

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

All About Faces

Hummelstown, Pennsylvania, 17036, United States

Location

Laser & Cosmetic Center

Virginia Beach, Virginia, 23462, United States

Location

Cosmedica Laser Centre

Victoria, British Columbia, V8R 6V4, Canada

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Lupin, MD

  Cosmedica Laser Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: January 31, 2018

Record last verified: 2016-10

Locations

CA (1); US (4)