Trial Outcomes & Findings for Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles (NCT NCT01299103)

Results Overview

Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.

Results posted on

2016-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Single Treatment Subjects receive one treatment	Double Treatment Subjects receive two treatments	Triple Treatment Subjects receive three treatments
Overall Study STARTED	15	15	10
Overall Study COMPLETED	15	13	8
Overall Study NOT COMPLETED	0	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Treatment n=15 Participants Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System	Double Treatment n=15 Participants Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System	Triple Treatment n=10 Participants Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System	Total n=40 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 7.2 • n=5 Participants	52 years STANDARD_DEVIATION 6.5 • n=7 Participants	53 years STANDARD_DEVIATION 5.2 • n=5 Participants	52 years STANDARD_DEVIATION 6.3 • n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	10 participants n=5 Participants	40 participants n=4 Participants

PRIMARY outcome

Timeframe: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.

Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease

Outcome measures

Outcome measures
Measure	Single Treatment n=15 Participants Subjects receive one treatment	Double Treatment n=13 Participants Subjects receive two treatments	Triple Treatment n=8 Participants Subjects receive three treatments
Fitzpatrick Wrinkle Assessment	1.0 units on a scale, change in Fitzpatrick Standard Deviation 0.98	1.5 units on a scale, change in Fitzpatrick Standard Deviation 1.9	1.1 units on a scale, change in Fitzpatrick Standard Deviation 1.7

PRIMARY outcome

Timeframe: 90 days post treatment

The rate of adverse events occurring in treatment subjects will be assessed.

Outcome measures

Outcome measures
Measure	Single Treatment n=15 Participants Subjects receive one treatment	Double Treatment n=13 Participants Subjects receive two treatments	Triple Treatment n=8 Participants Subjects receive three treatments
Adverse Events	0 number of adverse events reported	0 number of adverse events reported	0 number of adverse events reported

Adverse Events

Single Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Triple 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

Dr. Steven Dayan

Chicago Center for Facial Plastic Surgery

Phone: (312) 335-2070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place