LaseMD System for the Treatment of Melasma

NCT03456674 | Active Not Recruiting FDA Device

• 1 other identifier: L18002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical outcomes associated with use of the LaseMD Laser System for the treatment of melasma.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Improvement in the Melasma Area and Severity Index (MASI) from Baseline

  A change in MASI score from baseline to post-treatment. The MASI quantifies the pigmentation area, darkness, and homogeneity, assessing four areas of the face for hyperpigmentation: forehead, right malar region, left malar region and chin, corresponding to 30%, 30%, 30% and 10% of the total face. The melasma area in each region is given a numeric value from 1 (\<10%) to 6 (90-100%) in each of the four regions. Darkness of pigment is compared to normal skin in each area on a scale of 0 (absent) to 4 (severe). Homogeneity is based on a scale of 0 (minimal) to 4 (maximal). The MASI score is then calculated as the sum of severity rating of darkness and homogeneity, multiplied by the value of area involved. The maximum score is 48; the minimum score is 0.

  From baseline to 30 Days following the last study treatment.

Secondary Outcomes (6)

• Improvement in the Melasma Area and Severity Index (MASI) from Baseline

  From baseline to Days 90 and 180 following the last study treatment.

• Clinician assessment of overall aesthetic improvement.

  From baseline to Days 30, 90 and 180 following last treatment.

• Subject assessment of overall aesthetic improvement.

  From baseline to Days 30, 90 and 180 following last treatment.

• Improvement in the Melasma Quality of Life Scale (MELASQOL) from baseline

  From baseline to Day 30 following last treatment.

• Patient Satisfaction Questionnaire

  Day 30 following last treatment.

Study Arms (1)

LaseMD System

EXPERIMENTAL

Subjects will receive LaseMD System treatment(s) for treatment of melasma.

Device: LaseMD System

Interventions

LaseMD System DEVICE

A non-invasive fractional thulium laser delivering a wavelength of light energy as a fractionated array of microbeams to be absorbed by and damage the target molecule, a chromophore.

LaseMD System

Eligibility Criteria

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

You may qualify if:

• Female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to IV.
• Moderate to severe melasma (Melasma Severity Scale, score 2 or 3).
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
• 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:

• Inability to understand the protocol or to give informed consent.
• 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.
• 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 sensitivity or allergy to pre-treatment medication, EMLA Cream (Lidocaine/Prilocaine).
• Subjects with sensitivity or allergy to post-treatment cosmeceuticals, Tranexamic Acid and/or coconut.
• 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.
• Subjects who are pregnant or lactating or anticipate becoming pregnant during the study.
• Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (1)

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kari Larson, MBA

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single cohort of study subjects will receive study treatment.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 7, 2018
• Study Start: February 7, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)