Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
Completed · Not applicable
Conditions studied: Skin Laxity
In brief
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.
Key facts
- Study ID
- NCT01708252
- Run by
- Ulthera, Inc
- People needed
- 4
- Starts
- 2011-09-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2017-11-24
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, age 30 to 65 years.
- Subject in good health.
- BMI < 30.
- Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
- Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
- Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.
You may not qualify if…
- Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheeks.
- Excessive skin laxity on the lower face and neck
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated
Where it is running
- DeNova Research — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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