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

Ulthera, Inc5 sites in 2 countries88 target enrollmentMay 2014

ConditionsErythematotelangiectatic Rosacea Rosacea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Erythematotelangiectatic Rosacea
Sponsor: Ulthera, Inc
Enrollment: 88
Locations: 5
Primary Endpoint: Clinician Erythema Assessment at 90 days post-treatment compared to baseline
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

October 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ulthera, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).
•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 .

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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