Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea (NCT02144181) | Clinical Trial Compass
CompletedNot Applicable
Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea
United States, Canada88 participantsStarted 2014-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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).
Exclusion criteria
✕0. 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 .
✕1. Absence of physical or psychological conditions unacceptable to the investigator.
What they're measuring
1
Clinician Erythema Assessment at 90 days post-treatment compared to baseline
✕2. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
✕3. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
✕. 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.