Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 11/25/2017 |
| Start Date: | September 2012 |
| End Date: | August 2013 |
Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck
Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups.
Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the
left side. Group B will receive Thermage on the right side of the face and neck and
Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.
Study images will be obtained pre-treatment, immediately post-treatment, and at each
follow-up visit.
Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the
left side. Group B will receive Thermage on the right side of the face and neck and
Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.
Study images will be obtained pre-treatment, immediately post-treatment, and at each
follow-up visit.
This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A
triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects
to the full half face, neck, and submental areas. Changes in face and neck skin laxity and
wrinkles, from baseline and between study treatments, will be assessed at study follow-up
visits. Patient satisfaction questionnaires will also be obtained.
triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects
to the full half face, neck, and submental areas. Changes in face and neck skin laxity and
wrinkles, from baseline and between study treatments, will be assessed at study follow-up
visits. Patient satisfaction questionnaires will also be obtained.
Inclusion Criteria:
- Male or female, age 30 to 65 years.
- Subject in good health.
- Skin laxity on the area(s) to be treated.
- 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.
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) to be treated.
- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic acne on the area(s) to be treated.
- Presence of a metal stent or implant in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment
area(s) within two weeks prior to study participation or during the study.
- Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick
sebaceous skin in the area(s) to be treated.
- BMI equal to or greater than 25.
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