Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences (NCT03599349) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences
United States20 participantsStarted 2015-08-20
Plain-language summary
Evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs) produced during a treatment with the Ulthera System make contact with anatomical layers of the skin and underlying tissues.
Who can participate
Age range30 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject in good health.
✓. Mild to moderate skin laxity on the area(s) to be treated.
✓. Subject is pre-menopausal (treated in first week of cycle) or post-menopausal.
✓. Subject forehead's sub-dermal layer is at least a depth of 4.5mm using the 7-4.5mm transducer.
✓. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion criteria
✕. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if the following conditions is documented on the medical history:
✕. Absence of physical or psychological conditions unacceptable to the investigator.
✕. 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 i.e a maximum of 2-3 doses, in any 2 weeks period.
✕0. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
What they're measuring
1
Determine if There is a Correlation Between D90 Quantitative Efficacy Results of the Eyebrow and Lower Face Region With Where the TCPs Produced During Ultherapy Treatment Make Contact With Anatomical Layers of the Skin and Underlying Tissues.