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Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles (NCT NCT02091089)

NCT ID: NCT02091089

Last Updated: 2020-11-27

Results Overview

Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure
755nm Alexandrite Laser
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Overall Study
STARTED
20
Overall Study
COMPLETED
18
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
755nm Alexandrite Laser
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Overall Study
Lost to Follow-up
2

Baseline Characteristics

Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
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
0 Participants
n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
20 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Asian
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
0 Participants
n=5 Participants
Fitzpatrick Skin Type
I
0 Participants
n=5 Participants
Fitzpatrick Skin Type
II
7 Participants
n=5 Participants
Fitzpatrick Skin Type
III
11 Participants
n=5 Participants
Fitzpatrick Skin Type
IV
2 Participants
n=5 Participants
Fitzpatrick Skin Type
V
0 Participants
n=5 Participants
Fitzpatrick Skin Type
VI
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Outcome measures

Outcome measures
Measure
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Photographic Evaluation of Wrinkle Severity at Baseline
5.7 score on a scale
Standard Deviation 0.80

PRIMARY outcome

Timeframe: 1 Month Follow Up Post Last Treatment

Population: One subject did not show up to their follow up appointment.

Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Outcome measures

Outcome measures
Measure
755nm Alexandrite Laser
n=19 Participants
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up
3 score on a scale
Standard Deviation 1.25

PRIMARY outcome

Timeframe: 3 Month Follow Up Post Last Treatment

Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Outcome measures

Outcome measures
Measure
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up
3 score on a scale
Standard Deviation 1.28

PRIMARY outcome

Timeframe: 4 months post last treatment

Population: 2 subjects did not show up for their follow ups.

Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Outcome measures

Outcome measures
Measure
755nm Alexandrite Laser
n=18 Participants
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up
3 score on a scale
Standard Deviation 1.11

PRIMARY outcome

Timeframe: 6 months post last treatment

Population: 2 subjects did not show up for their follow ups.

Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

Outcome measures

Outcome measures
Measure
755nm Alexandrite Laser
n=18 Participants
755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up
3 score on a scale
Standard Error 1.23

Adverse Events

755nm Alexandrite Laser

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

Jamie Trimper

Cynosure

Phone: 800-886-2966

Results disclosure agreements

  • Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
  • Publication restrictions are in place

Restriction type: OTHER