NCT01279226

Brief Summary

The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 3, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

January 14, 2011

Last Update Submit

November 30, 2012

Conditions

Laxity of Skin

Outcome Measures

Primary Outcomes (1)

  • Improved cosmesis

    Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.

    2-6 timepoints from 4 days to 6 months

Interventions

Auralevée deviceDEVICE

Single treatment with Auralevée device.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female at least 21 years old,
  • Apparently healthy,
  • Informed consent signed by the subject.

You may not qualify if:

  • Tobacco smokers,
  • History of skin hypersensitivity,
  • Current skin disorder or infection (e.g., herpes simplex),
  • Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
  • Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
  • Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
  • The current or recent use (within the past 12 months) of isotretinoin,
  • Pregnancy or breast feeding,
  • Insulin dependent diabetic subjects,
  • Oxygen dependent subjects,
  • Subjects with severe chronic illness, scleroderma, or lupus,
  • Subjects with open sores or scars in the treatment region, or
  • Subjects with ischemia in the treatment region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laser Treatment Center

Kirkland, Washington, 98034, United States

Location

Study Officials

  • Peter Cooperrider, MD

    Laser Treatment Center

    PRINCIPAL INVESTIGATOR

  • Stephen Flock, PhD

    Rocky Mountain Biosystems, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

December 3, 2012

Record last verified: 2012-10

Locations

US(1)