Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 11/25/2017 |
| Start Date: | September 2011 |
| End Date: | August 2012 |
Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ 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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
