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Outcome Measures

Primary Outcomes (2)

Group A: Evaluation of split-side pigmentary clearance
Blinded assessment of paired post-treatment study photographs conducted by three blinded physician evaluators will compare split-side post-treatment photos. Each assessor will be given identical paired post-treatment photo sets. Each photo's treatment device (LaseMD or DUAL 1927nm) will NOT be marked. Each assessor will compare the Left and Right photo for improvement in benign pigmented lesions using the following definitions: Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature. The photo believed to be the most improved photo (Left photo or Right photo) is selected.
90 days following the last study treatment
Group B: Percentage of pigmentary clearance in standard photographs
Blinded assessment of paired study photographs conducted by three blinded physician assessors will compare pre- and post-treatment photos. Each assessor will compare paired photo sets for percentage of pigmentary clearance using a score of 0-4: 0=poor (0-24%), 1=fair (25-49%), 2=good (50-74%), 3=excellent (75-95%), 4=complete (95%+) improvement. Each assessor will be given identical paired pre- and post-treatment photo sets. Each photo's visit interval (pre and post treatment) will NOT be marked. Each assessor will compare Left and Right photo for improvement in benign pigmented lesions using the following definitions: * Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature. The photo believed to be the post-treatment photo (Left photo or Right photo) is selected. The assessor will then score the percentage of pigmentary clearance using the 0-4 scale.
90 days following the last study treatment

Secondary Outcomes (4)

Clinician assessment of overall aesthetic improvement
28 and 90 days following study treatments
Subject assessment of overall aesthetic improvement
28 and 90 days following study treatments
Patient Satisfaction Questionnaire
90 days following study treatment
Treated-related pain
For the duration of each study treatment

Study Arms (2)

Group A: LaseMD and DUAL 1927nm Laser

ACTIVE COMPARATOR

Group A subjects will receive split-side study treatments comparing two devices: LaseMD compared to the DUAL 1927nm laser.

Device: LaseMD and DUAL 1927nm Laser

Group B: LaseMD Optimized

ACTIVE COMPARATOR

Group B subjects will receive LaseMD Optimized Treatments based on Group A treatment data.

Device: LaseMD

Interventions

LaseMD and DUAL 1927nm LaserDevice

Laser treatment of benign pigmented lesion based on photothermolysis whereby the target molecule, the chromophore, absorbs a delivered wavelength of light over a period of time to damage the target while limiting collateral damage to adjacent structures, leading to pigmentary clearance.

Group A: LaseMD and DUAL 1927nm Laser

LaseMDDevice

Laser treatment of benign pigmented lesion using optimized treatment settings.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

NON RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Group A: Three blinded physician evaluators will assess an identical set of split side post-treatment photos, comparing the left and right photo for improvement in benign pigmented lesions. Group B: Three blinded physician evaluators will assess an identical set of pre-treatment and post-treatment photos, comparing the left and right photo for improvement in benign pigmented lesions.

Purpose

TREATMENT

Intervention Model

SEQUENTIAL

Model Details: Subjects will be enrolled first into Group A, then Group B will be enrolled. Subjects may not be enrolled in both groups.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Lutronic LaseMD for Treatment of Benign Pigmented Lesions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group A: LaseMD and DUAL 1927nm Laser

Group B: LaseMD Optimized

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Group A: LaseMD and DUAL 1927nm Laser

Group B: LaseMD Optimized

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations