Trial Outcomes & Findings for Thigh Circumference Reduction Study (NCT NCT00953290)

NCT ID: NCT00953290

Last Updated: 2011-05-10

Results Overview

Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline and 6 months post final treatment
• Results posted on: 2011-05-10

Participant Flow

The study subjects were recruited in the medical clinic 01/30/09 through 04/07/09.

Participant milestones

Measure	Treated and Untreated Thigh Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thigh Circumference Reduction Study

Baseline characteristics by cohort

Measure	Treated And Untreated Thigh n=4 Participants Treated and untreated arms (left and right thighs) on the same subject.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	43 years STANDARD_DEVIATION 10.98 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months post final treatment

Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]

Outcome measures

Measure	Treated and Untreated Upper Thigh n=8 Upper Thigh Treated and untreated arms (left and right thigh) on the same participant
Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms	1.0 cm Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline and 6 months post final treatment

Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]

Outcome measures

Measure	Treated and Untreated Upper Thigh n=8 Mid Thigh Treated and untreated arms (left and right thigh) on the same participant
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms	0.63 cm Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline and 6 months post final treatment

Population: Data was not collected due to termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At each visit (treatment and follow-up) or until resolution of AEs

Outcome measures

Measure	Treated and Untreated Upper Thigh n=4 Thighs (left or right) Treated and untreated arms (left and right thigh) on the same participant
Adverse Events Lumps	3 Event
Adverse Events Erythema	2 Event
Adverse Events Edema	2 Event
Adverse Events Bruising	2 Event
Adverse Events Sensitivity	3 Event
Adverse Events Discomfort	3 Event

Adverse Events

Treated Thigh

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treated Thigh n=4 participants at risk
Injury, poisoning and procedural complications Erythema	50.0% 2/4 • Number of events 2 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.
Injury, poisoning and procedural complications Edema	50.0% 2/4 • Number of events 2 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.
Injury, poisoning and procedural complications Bruising	50.0% 2/4 • Number of events 2 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.
Injury, poisoning and procedural complications Lumps	75.0% 3/4 • Number of events 3 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.
Injury, poisoning and procedural complications Sensitivity	75.0% 3/4 • Number of events 3 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.
Injury, poisoning and procedural complications Discomfort	75.0% 3/4 • Number of events 3 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.

Additional Information

Ayse Turley, Clinical Development Researcher

Cutera Inc.

Phone: 415-657-5665

Email: aturley@cutera.com

Results disclosure agreements

• Principal investigator is a sponsor employee Prepare the study results for publication and presentation in cooperation with Cutera. The Doctor will not publish or present the results of the Study, or speak publicly about it, unless Cutera has first had a reasonable opportunity to review and comment on the contents of the proposed presentation or publication.
• Publication restrictions are in place

Restriction type: OTHER