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Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences | Clinical Trials | Clareo Health

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Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

NCT03599349•Ulthera, Inc

View on ClinicalTrials.gov

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.

Detailed Description

This is a prospective, single-site, non-randomized study designed to evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs), produced during treatment with the Ulthera System, make contact with the anatomical layers of skin and underlying tissues. The study consists of one Ultherapy treatment administered at two depths using DeepSEE transducers on the full-face and neck area. Ultrasound images will be captured at the beginning, middle and end of each treatment section during treatment.

Eligibility

Age

30 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject in good health.
•2. Mild to moderate skin laxity on the area(s) to be treated.
•3. Subject is pre-menopausal (treated in first week of cycle) or post-menopausal.
•4. Subject forehead's sub-dermal layer is at least a depth of 4.5mm using the 7-4.5mm transducer.
•5. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
•6. 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.
•7. 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:
•a. Bilateral tubal ligation at least six months prior to study enrollment.
•8. Absence of physical or psychological conditions unacceptable to the investigator.
•9. 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.
+2 more criteria

Exclusion Criteria

•1. Presence of an active systemic or local skin disease that may affect wound healing.
•2. Severe solar elastosis.
•3. Excessive subcutaneous fat in the area(s) to be treated.
•4. Excessive skin laxity on the area(s) to be treated.
•5. Significant scarring in the area(s) to be treated that would interfere with assessing results.
•6. Open wounds or lesions in the area(s) to be treated.
•7. Severe or cystic acne on the area(s) to be treated.
•8. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
•9. Inability to understand the protocol or to give informed consent.
•10. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
+26 more criteria

Locations (1)

Clinical Testing of Beverly Hills

Beverly Hills, California, United States

Key Dates

Start Date

August 20, 2015

Primary Completion Date

July 13, 2016

Completion Date

July 13, 2016

Last Updated

June 11, 2019

Enrollment

ACTUAL participants

Conditions

Facial and Neck Skin Laxity

Interventions

Microfocused ultrasound w/ visualization

DEVICE