Trial Outcomes & Findings for Prospective Pellevé™ Neck Wrinkle Study (NCT NCT01299090)

Results Overview

Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study. The measurement is for percentage of patients who showed improvement

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

90 days post treatment

Results posted on

2016-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group All subjects enrolled were in the treatment group. Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Pellevé™ Neck Wrinkle Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=49 Participants All subjects enrolled were in the treatment group. Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart
Age, Continuous	61 years STANDARD_DEVIATION 8.1 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post treatment

Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study. The measurement is for percentage of patients who showed improvement

Outcome measures

Outcome measures
Measure	Treatment Group n=49 Participants All subjects enrolled were in the treatment group. Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart
Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment	74 percentage of participants

PRIMARY outcome

Timeframe: 90 days post treatment

The rate of adverse events will be assessed throughout the duration of the study

Outcome measures

Outcome measures
Measure	Treatment Group n=49 Participants All subjects enrolled were in the treatment group. Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	0 participants

Adverse Events

Treatment Group

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

Lisa Chipps, MD

Moy, Fincher, Chipps Medical Group

Phone: (310) 274-5372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place