Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00894244
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Radiofrequency device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Treatment using a non-invasive skin tightening radiofrequency device to observe skin shrinkage in the arms	Device: Radiofrequency device; One treatment pass on one arm. 2-5 treatment passes on the other

Outcome Measures

Primary Outcome Measures

1. The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters) [immediately following treatment and 30 days after last treatment]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 30-60 y/o

• Mild to moderate laxity of arm skin

• Skin of Fitzpatrick levels I-III

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
• ClinicalTrials.gov Identifier: NCT00894244
• Other Study ID Numbers: STU1178
• First Posted: May 6, 2009
• Last Update Posted: Dec 28, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University: None- Normal healthy upper arm skin will be used.

Study Results

Participant Flow

Recruitment Details	The principal investigator will select patients presenting to the Dermatology Clinic at Northwestern Memorial Hospital who meet the inclusion criteria. These individuals will be referred to the trained researcher running the study. A brief, written description of the study will be given to the patient.

Arm/Group Title	Thermage
Arm/Group Description	Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
Period Title: Overall Study
STARTED	25
COMPLETED	24
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Thermage
Arm/Group Description	Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 80%
>=65 years	5 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (1.78)
Sex: Female, Male (Count of Participants)
Female	25 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)
Description	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
Time Frame	immediately following treatment and 30 days after last treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Thermage
Arm/Group Description	Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
Measure Participants	24
Number (95% Confidence Interval) [millimeters]	45.17

Adverse Events

Adverse Event Reporting Description	Adverse events included pain during the treatment when using the higher energy setting or treatment on the anterior, immediate erythema and swelling. However, none of the subjects experienced adverse events.
Arm/Group Title	Thermage
Arm/Group Description	Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
All Cause Mortality
	Thermage
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Thermage
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Thermage
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.