Trial Outcomes & Findings for Lutronic PicoPlus Exploratory Clinical Trial (NCT NCT03415685)

Last Updated: 2023-12-20

Results Overview

Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)

Recruitment status

TERMINATED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Up to 6 Months following final study treatment

Results posted on

2023-12-20

Participant Flow

Subjects were assigned a group depending on the condition that was to be treated as part of their participation in the study.

Participant milestones

Participant milestones
Measure	Group A: PicoPlus for Unwanted Tattoos. Subjects receiving PicoPlus laser system treatment for unwanted tattoos. Subjects can receive up to 8 treatments with a standard interval of 6-8 weeks between treatments. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.	Group B: PicoPlus for Other Dermatological Conditions Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. Subjects can receive up to 8 treatments with a standard interval of 3-5 weeks between treatments. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
Overall Study STARTED	11	28
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lutronic PicoPlus Exploratory Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: PicoPlus for Unwanted Tattoos. n=11 Participants Subjects receiving PicoPlus laser system treatment for unwanted tattoos. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.	Group B: PicoPlus for Other Dermatological Conditions n=28 Participants Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.	Total n=39 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 6.9 • n=5 Participants	43.6 years STANDARD_DEVIATION 15.4 • n=7 Participants	38.7 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	28 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 Months following final study treatment

Population: \# of subjects who returned for FU assessment prior to study termination

Outcome measures

Outcome measures
Measure	Group A: PicoPlus for Unwanted Tattoos. n=6 Participants Subjects receiving PicoPlus laser system treatment for unwanted tattoos. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.	Group B: PicoPlus for Other Dermatological Conditions n=8 Participants Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
Investigator's Global Assessment of Improvement 3 = Very significant or complete clearing (75-100%)	1 Participants	6 Participants
Investigator's Global Assessment of Improvement 2 = Significant clearing (50-74%)	2 Participants	0 Participants
Investigator's Global Assessment of Improvement 1 = Moderate clearing (25-49%)	3 Participants	2 Participants
Investigator's Global Assessment of Improvement 0 = Mild or no clearing (0-24%)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month, 3 Months, 6 Months (Group A Only) post final treatment

Population: A subset of subjects (6 in Group A, 9 in Group B) returned for a 1-month follow-up prior to termination of the study with results reported in the corresponding table.

Overall aesthetic improvement based on completion of the Subject's Global Assessment of Improvement Scale. Subjects will be asked review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)

Outcome measures

Outcome measures
Measure	Group A: PicoPlus for Unwanted Tattoos. n=6 Participants Subjects receiving PicoPlus laser system treatment for unwanted tattoos. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.	Group B: PicoPlus for Other Dermatological Conditions n=9 Participants Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
Subject's Global Assessment of Improvement 3 = Very significant or complete clearing (75-100%)	0 Participants	6 Participants
Subject's Global Assessment of Improvement 2 = Significant clearing (50-74%)	3 Participants	3 Participants
Subject's Global Assessment of Improvement 1 = Moderate clearing (25-49%)	3 Participants	0 Participants
Subject's Global Assessment of Improvement 0 = Mild or no clearing (0-24%)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month, 3 Months, 6 Months (Group A Only) post final treatment

Population: Data cannot be reported as satisfaction data was not collected at the time of patient visits.

Following the final study treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale and the following definitions: 2 = Extremely Satisfied 1 = Satisfied 0 = Neutral (-1) = Unsatisfied (-2) = Extremely Unsatisfied

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-month (Group B), 6 months (Group A) Post Final treatment

Population: Due to study termination a blinded review was not completed for the subject images in the study and thus there is no data to report.

Three blinded experienced, non-treating clinicians will independently evaluate pre- and post-treatment photos of each subject, presented randomly. Each reviewer will be asked to determine the temporal order (before and after) of each photo pair, and then rate the degree of tattoo clearing or reduction in benign pigmentation in the post-treatment photo using the following scale: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months (Group B), 6 Months (Group A) post final treatment

Population: MASI scoring was not completed for participants in the study as the study was terminated and Blinded Reviewers did not evaluate the photos.

Three blinded experienced, non-treating clinicians will independently evaluate pre- and post-treatment photos of each subject, presented randomly, using the MASI. Each of four regions (forehead, right malar region, left malar region and chin) will be assessed based on three variables: percentage of the total area involved (A), darkness (D), and homogeneity (H).

Outcome measures

Outcome data not reported

Adverse Events

Group A: PicoPlus for Unwanted Tattoos.

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group B: PicoPlus for Other Dermatological Conditions

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Alexander Denis, Global Manager of Clinical Research

Lutronic

Phone: 9788959206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group A: PicoPlus for Unwanted Tattoos. n=11 participants at risk Subjects receiving PicoPlus laser system treatment for unwanted tattoos. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.	Group B: PicoPlus for Other Dermatological Conditions n=28 participants at risk Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. PicoPlus laser system: Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
Skin and subcutaneous tissue disorders Darkening of Lesions	9.1% 1/11 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.	10.7% 3/28 • Number of events 8 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Blisters/Scabs/Crusting	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	7.1% 2/28 • Number of events 4 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Bruising/Ecchymosis	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Edema	9.1% 1/11 • Number of events 3 • Adverse events were collected up to 6 months post final treatment.	25.0% 7/28 • Number of events 13 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Erythema	18.2% 2/11 • Number of events 4 • Adverse events were collected up to 6 months post final treatment.	35.7% 10/28 • Number of events 23 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Bleeding of Ink	9.1% 1/11 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.	0.00% 0/28 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Treatment Discomfort	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Dryness	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Heat Sensation	9.1% 1/11 • Number of events 2 • Adverse events were collected up to 6 months post final treatment.	0.00% 0/28 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Hypo/Hyper-Pigmentation	9.1% 1/11 • Number of events 2 • Adverse events were collected up to 6 months post final treatment.	10.7% 3/28 • Number of events 3 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Itching/Pruritis	18.2% 2/11 • Number of events 6 • Adverse events were collected up to 6 months post final treatment.	17.9% 5/28 • Number of events 6 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Skin Bumps	9.1% 1/11 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.	0.00% 0/28 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Roughness	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Scabbing/Peeling	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	14.3% 4/28 • Number of events 4 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Tightness	0.00% 0/11 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.
Skin and subcutaneous tissue disorders Welting/Raised Area of Edema	9.1% 1/11 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.	3.6% 1/28 • Number of events 1 • Adverse events were collected up to 6 months post final treatment.