NCT00894244

Brief Summary

This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 3, 2012

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

May 5, 2009

Results QC Date

February 7, 2012

Last Update Submit

December 1, 2021

Conditions

Healthy

Keywords

None- Normal healthy upper arm skin will be used.

Outcome Measures

Primary Outcomes (1)

  • The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)

    The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment

    immediately following treatment and 30 days after last treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms

Device: Radiofrequency device

Interventions

Radiofrequency deviceDEVICE

One treatment pass on one arm. 2-5 treatment passes on the other

Treatment

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-60 y/o
  • Mild to moderate laxity of arm skin
  • Skin of Fitzpatrick levels I-III

You may not qualify if:

  • Any active local arm infections
  • Scarring or abnormalities in upper arm area
  • Major systemic illnesses
  • Any condition with delayed wound healing
  • History of psychiatrist illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

Title
Dr. Murad Alam
Organization
Northwestern University
m-alam@northwestern.edu
(312) 695-6785

Publication Agreements

PI is Sponsor Employee
Yes

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
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 28, 2021

Results First Posted

September 3, 2012

Record last verified: 2021-12

Locations

US(1)