Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01708928
Other study ID # ULT-107
Secondary ID
Status Completed
Phase N/A
First received October 15, 2012
Last updated November 22, 2017
Start date August 2010
Est. completion date August 2012

Study information

Verified date June 2013
Source Merz Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.


Description:

This is a prospective single center study. Subjects will be enrolled one per group as they present. Efficacy will be determined by the change in submental volume and cervicomental angle. GAIS and patient satisfaction questionnaires will also be obtained.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

- Male or female, aged 30 to 65 years

- Subject in good health

- Body Mass index of less than 30

- Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle

- Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment

- Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit

- 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 at Visit 1 and be willing able to use an acceptable method of birth control

Exclusion Criteria:

- Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control

- Has an active systemic or local skin disease that may alter wound healing

- Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months

- Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country Name City State
United States DeNova Research Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in submental volume Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos. 90 days post-treatment
Secondary Overall improvement of the submental area Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained. 90 days post-treatment
See also
  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