Trial Outcomes & Findings for Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles (NCT NCT02091102)
NCT ID: NCT02091102
Last Updated: 2020-11-25
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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
COMPLETED
NA
20 participants
6 Month Follow Up Post Last Treatment
2020-11-25
Participant Flow
Participant milestones
| Measure |
755nm Alexandrite Laser
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Baseline characteristics by cohort
| Measure |
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type Score
I
|
4 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type Score
II
|
15 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type Score
III
|
1 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type Score
IV
|
0 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type Score
V
|
0 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type Score
VI
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselineBlinded 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Outcome measures
| Measure |
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Photographic Evaluation of Wrinkle Severity at Baseline
|
5.25 score on a scale
Standard Deviation .851
|
PRIMARY outcome
Timeframe: 1 Month Follow Up Post Last TreatmentPopulation: One subject was unable to return to clinic for the 1 month visit due to a family emergency.
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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Outcome measures
| Measure |
755nm Alexandrite Laser
n=19 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
|
4.74 score on a scale
Standard Deviation .991
|
PRIMARY outcome
Timeframe: 3 Month Follow Up Post Last TreatmentBlinded 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Outcome measures
| Measure |
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
|
4.25 score on a scale
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: 4 Month Follow Up Post Last TreatmentBlinded 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Outcome measures
| Measure |
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
|
3.9 score on a scale
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: 6 Month Follow Up Post Last TreatmentBlinded 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Outcome measures
| Measure |
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
|
4 score on a scale
Standard Deviation 1.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 months post last treatmentOutcome measures
Outcome data not reported
Adverse Events
755nm Alexandrite Laser
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
755nm Alexandrite Laser
n=20 participants at risk
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles
|
|---|---|
|
Nervous system disorders
pain
|
25.0%
5/20 • The adverse event data were collected up to 6 months post last treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
85.0%
17/20 • The adverse event data were collected up to 6 months post last treatment.
|
|
Skin and subcutaneous tissue disorders
Edema
|
35.0%
7/20 • The adverse event data were collected up to 6 months post last treatment.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.0%
1/20 • The adverse event data were collected up to 6 months post last treatment.
|
|
Skin and subcutaneous tissue disorders
Itching
|
15.0%
3/20 • The adverse event data were collected up to 6 months post last treatment.
|
|
Skin and subcutaneous tissue disorders
Dryness
|
5.0%
1/20 • The adverse event data were collected up to 6 months post last treatment.
|
Additional Information
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