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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT02364440 |
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Date of registration:
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10/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
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Scientific title:
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Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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7 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02364440 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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ChangSik Pak, Bachelor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Bundang Hospital |
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Key inclusion & exclusion 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
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wrinkles
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Intervention(s)
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Device: Ultherapy™ System
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Primary Outcome(s)
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Investigator's evaluation of 5-point Hand grading scale
[Time Frame: 12 weeks post-treatment]
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Secondary Outcome(s)
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Subject Assessment of Improvement at 12 weeks post-treatment
[Time Frame: 12 weeks post-treatment]
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Subjects' Assessment of Pain during treatment
[Time Frame: Subjects were assessed for the duration of study treatment]
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Investigator Assessment of Improvement at 12 weeks post-treatment
[Time Frame: 12 weeks post-treatment]
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Secondary ID(s)
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E-1405/250-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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