Skin Laxity Clinical Trial
Official title:
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs
Verified date | September 2013 |
Source | Merz Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. 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.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female, age 30 to 65 years. - Subject in good health. - Skin laxity in the buttocks and thighs. - Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss 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. - Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment. Exclusion Criteria: - Presence of an active systemic or local skin disease that may affect wound healing. - BMI equal to or greater than 40. - Excessive subcutaneous fat in the buttocks and thighs. - Excessive skin laxity in the buttocks and thighs. - Significant weight fluctuation (±10 lbs) in the past 6 months. - Taking weight-loss medications/supplements. - Surgical or non-surgical treatments to the target areas in the last 12 months, e.g., liposuction. - Inability to understand the protocol or to give informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Skin Laser and Surgery Specialist of New York and New Jersey | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Ulthera, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall lifting and tightening of the buttocks and thighs. | As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline. | 90 days post-treatment | |
Secondary | Overall aesthetic improvement. | As determined by GAIS completed by the Investigator and subject. | 90 and 180 days post-treatment. | |
Secondary | Overall subject satisfaction. | As determined by subjects' completion of a Patient Satisfaction Questionnaire. | 90 and 180 days post-treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06140628 -
A 28-day Clinical Study on Facial Skin Rejuvenation
|
N/A | |
Completed |
NCT01971736 -
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening
|
N/A | |
Completed |
NCT01713985 -
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck
|
N/A | |
Completed |
NCT01708382 -
Feasibility Study: Lifting and Tightening of the Elbows
|
N/A | |
Completed |
NCT01713998 -
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
|
N/A | |
Completed |
NCT01708252 -
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
|
N/A | |
Completed |
NCT04296201 -
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
|
N/A | |
Completed |
NCT06000839 -
A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)
|
N/A | |
Completed |
NCT06366503 -
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
|
N/A | |
Completed |
NCT05929625 -
Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation
|
N/A | |
Terminated |
NCT01713569 -
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System
|
N/A | |
Completed |
NCT01519934 -
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
|
N/A | |
Completed |
NCT05605691 -
Post-Market Lower Eyelid Treatment With Renuvion in Greece
|
N/A | |
Completed |
NCT04477187 -
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
|
N/A | |
Completed |
NCT05590364 -
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
|
N/A | |
Active, not recruiting |
NCT06243744 -
Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery
|
N/A | |
Completed |
NCT04146584 -
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
|
Phase 2 | |
Recruiting |
NCT05750901 -
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
|
N/A | |
Completed |
NCT04721600 -
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
|
N/A | |
Recruiting |
NCT06157567 -
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
|
N/A |