Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

Completed · Not applicable

Conditions studied: Erythematotelangiectatic Rosacea, Rosacea

In brief

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.

Key facts

Study ID: NCT02144181
Run by: Ulthera, Inc
People needed: 88
Starts: 2014-05-01
Expected to finish: 2016-10-01
Last updated by the study team: 2018-01-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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).
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.

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.
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.

Where it is running

Skin Specialists, PC — Omaha, Nebraska, United States
Wilmington Dermatology Center — Wilmington, North Carolina, United States
All About Faces — Hummelstown, Pennsylvania, United States
Laser & Cosmetic Center — Virginia Beach, Virginia, United States
Cosmedica Laser Centre — Victoria, British Columbia, Canada

Full record on ClinicalTrials.gov

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