Ultherapy™ Treatment Following Sculptra® Treatment
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 35 - 60 |
| Updated: | 12/15/2017 |
| Start Date: | May 2011 |
| End Date: | September 2012 |
Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
This clinical trial will evaluate clinical outcomes associated with the non-invasive
Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30)
subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up
to 10 subjects per group.
subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up
to 10 subjects per group.
Inclusion Criteria:
- Male or female, aged 35 to 60 years.
- Subject in good health.
- Skin laxity in the lower face and neck.
- Grade 1 and 2 on the Knize Scale
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face and neck.
- Excessive skin laxity on the face and neck.
- No scarring in areas to be treated.
- Any open facial wounds or lesions.
- Acne on the face.
- Patients who have a history with keloid formation or hypertropic scarring
- Patients who have a hypersensitivity to injectable poly-L-lactic acid
- Presence of a metal stent or implant in the facial area to be treated.
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