An interventional study of Ulthera System Treatment in Skin Laxity, sponsored by Ulthera, Inc. Completed at 1 site in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Ulthera, Inc · Not applicable, Interventional, and Treatment
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.
This study's enrollment of 4 is below the median of 30 across 129 interventional studies indexed under Cutis Laxa.
Browse Cutis Laxa studies →Ulthera, Inc is the lead sponsor of 46 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects will receive an Ulthera System Treatment
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Also known as: Ultherapy™
Improvement in lower face and neck skin laxity
Efficacy will be assessed using the 90-day images compared to baseline
Time frame: 90 days post-treatment
Cervicomental angle
Efficacy will be assessed using the 90-day images compared to baseline.
Time frame: 90 days post-treatment
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
Time frame: 90 days post-treatment
Patient satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
Time frame: 90 days post-treatment
Pain Assessment
Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
Time frame: Treatment visit
Patient Satisfaction
Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
Time frame: 180 days post-treatment
Overall aesthetic improvement
Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
Time frame: 180 days post-treatment
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Ulthera, Inc