Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté (NCT01485107) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
United States24 participantsStarted 2011-06
Plain-language summary
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
Who can participate
Age range35 Years – 60 Years
SexFEMALE
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Inclusion Criteria:
* Female, aged 35 to 60 years.
* Subject in good health.
* Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* 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.
Exclusion Criteria:
* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in areas to be treated.
* Tattoos in the areas to be treated.
* Patients with ports or defibrillators.
* Breast size \>400cc each as measured by water displacement method.
* History of breast reduction surgery.
* Any open wounds or lesions in the area.
* Active and severe inflammatory acne in the region to be treated.
* Patients who have a history with keloid formation or hypertropic scarring
What they're measuring
1
Improvement in overall lifting and tightening of skin