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Completed

NCT Number: NCT02364440

Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

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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Key information

Conditions

Wrinkles Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultherapy™ System

Device

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

Primary outcomes

  1. Investigator's evaluation of 5-point Hand grading scale

    Time frame: 12 weeks post-treatment

    2 assessors will be evaluate 5-point Hand grading scale from baseline and 12weeks post treatment

Secondary outcomes

  1. Subject Assessment of Improvement at 12 weeks post-treatment

    Time frame: 12 weeks post-treatment

    Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks post-treatment

  2. Investigator Assessment of Improvement at 12 weeks post-treatment

    Time frame: 12 weeks post-treatment

    Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs

  3. Subjects' Assessment of Pain during treatment

    Time frame: Subjects were assessed for the duration of study treatment

    Pain score record using a Numeric Rating Scale (NRS,0-10) , with 0 representing no pain and 10 representing the worst pain possible.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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