Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Seoul National University

Status: Completed

Conditions: Wrinkles

Treatments: Device: Ultherapy™ System

Study type: Interventional

Funder types: Other

Identifiers

NCT02364440

E-1405/250-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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7 participants in 1 patient group

Ultherapy™ System

Experimental group

Description:

Ultherapy™ System

Treatment:

Device: Ultherapy™ System