Lutronic LaseMD for Treatment of Benign Pigmented Lesions

NCT03409952 | Completed FDA Device

• 1 other identifier: L17001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.

Conditions

Benign Pigmented Lesions

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 Laser DEVICE

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

LaseMD DEVICE

Laser treatment of benign pigmented lesion using optimized treatment settings.

Group B: LaseMD Optimized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to VI.
• Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries; or
• Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• History of keloids or poor wound healing.
• Significant scarring in the area(s) to be treated that would interfere with assessing results.
• Open wounds or lesions in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
• Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• History of chronic drug or alcohol abuse.
• History of collagen vascular disease.
• History of autoimmune disease.
• Subjects with implanted pacemaker or defibrillator.
• Subjects with sensitivity or allergy to gold.
• Subjects with sensitivity or allergy to benzocaine, lidocaine, ortetracaine.
• Subjects with photosensitive skin.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (2)

Maryland Dermatology Laser, Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Dermatology, Laser, and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Kari Larson, MBA

  Sponsor GmbH

  STUDY DIRECTOR

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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: November 17, 2017
• Primary Completion: December 20, 2018
• Study Completion: February 25, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)