Trial Outcomes & Findings for Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction (NCT NCT00887913)

Results Overview

Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

4 week follow up after last treatment

Results posted on

2010-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Treatment group- undergo 3 treatments every 4-6 weeks
Overall Study STARTED	69
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Treatment group- undergo 3 treatments every 4-6 weeks
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=69 Participants Treatment group- undergo 3 treatments every 4-6 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	51.02 years STANDARD_DEVIATION 8.28 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Region of Enrollment Canada	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 week follow up after last treatment

Population: Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4

Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up

Outcome measures

Outcome measures
Measure	Treatment n=162 Fine Lines Treatment group- undergo 3 treatments every 4-6 weeks
Improvement in Fine Lines	1.77 Scores on a scale Standard Deviation 0.98

PRIMARY outcome

Timeframe: 4 weeks follow up post last treatment

Population: Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin

Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up

Outcome measures

Outcome measures
Measure	Treatment n=162 Smoothness Treatment group- undergo 3 treatments every 4-6 weeks
Improvement in Smoothness	1.90 Scores on a scale Standard Deviation 1.05

PRIMARY outcome

Timeframe: 4 week follow up post last treatment

Population: Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.

Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up

Outcome measures

Outcome measures
Measure	Treatment n=162 Brightness Treatment group- undergo 3 treatments every 4-6 weeks
Improvement in Brightness	1.68 Scores on a scale Standard Deviation 1.18

Adverse Events

Treatment

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

Hanit Brenner-Lavie

Syneron Medical Ltd

Phone: 972-73-244-2200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI is under a general confidentiality agreement and must have prior written approval by the Sponsor prior to publishing the study results.
Publication restrictions are in place

Restriction type: OTHER