NCT02364440

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

February 10, 2015

Last Update Submit

May 7, 2015

Conditions

Wrinkles

Keywords

skin laxityUltherapy™ Systemrhytids

Outcome Measures

Primary Outcomes (1)

  • Investigator's evaluation of 5-point Hand grading scale

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

    12 weeks post-treatment

Secondary Outcomes (3)

  • Subject Assessment of Improvement at 12 weeks post-treatment

    12 weeks post-treatment

  • Investigator Assessment of Improvement at 12 weeks post-treatment

    12 weeks post-treatment

  • Subjects' Assessment of Pain during treatment

    Subjects were assessed for the duration of study treatment

Study Arms (1)

Ultherapy™ System

EXPERIMENTAL

Ultherapy™ System

Device: Ultherapy™ System

Interventions

Ultherapy™ SystemDEVICE

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

Ultherapy™ System

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • ChangSik Pak, Bachelor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-02

Locations

KR(1)