Trial Outcomes & Findings for Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device (NCT NCT00894244)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

immediately following treatment and 30 days after last treatment

Results posted on

2021-12-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thermage n=25 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 1.78 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Thermage n=24 Participants 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
The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)	45.17 millimeters Interval 40.0 to 61.0

Adverse Events

Thermage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Murad Alam

Northwestern University

Phone: (312) 695-6785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place