Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands. Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained pre-treatment and at 90 days post-treatment

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Detailed Description

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Before Treatment:

The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the 5-point Hand Grading Scale wil be evaluated by the Investigator in charge of assessment.

Treatment:

The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 20 lines of 1.5 and 3.0 probe respectively to the back of the left and right hand .

Post-Treatment:

All subjects will visit the Institution at12 weeks from the day of procedure, and will take photos of the back of the hands. Efficacy evaluation will performed by the Photographic Evaluator.

Conditions

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Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultherapy™ System

Group Type EXPERIMENTAL

Ultherapy™ System

Intervention Type DEVICE

Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively

Interventions

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Ultherapy™ System

Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 30 to 65 years.
* Score of 1 to 3 on The 5-point Hand Grading Scale
* Subjects who understand the study contents and signed the informed consent

Exclusion Criteria

* Presence of an active systemic infectious disease
* Significant scarring in the hand to be treated
* Previous episode of surgery in the hand to be treated
* Subjects who have aesthetic addiction, drug abuse, alcohol abuse

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes