Healthy
Conditions
Keywords
None- Normal healthy upper arm skin will be used.
Brief summary
This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.
Interventions
DEVICERadiofrequency device
One treatment pass on one arm. 2-5 treatment passes on the other
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Thermage 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 | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Thermage |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 1.78 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
Time frame: immediately following treatment and 30 days after last treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thermage | The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters) | 45.17 millimeters |