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MelasmaNCT03456674

LaseMD System for the Treatment of Melasma

A study testing LaseMD System in people with Melasma, run by CynosureLutronic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Melasma
What is being tested?
LaseMD System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
7 Feb 2018to 30 Jun 2019
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
  • Concurrent enrollment in any study involving the use of investigational devices or drugs.
  • Current smoker or history of smoking in the last five years.
  • Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • History of surgical or cosmetic treatments in the area(s) to be treated within the past 6 months.
  • Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study.
  • History of hormone treatment, such as estrogen, progesterone and/or oral contraceptives, initiated within 3 months of study participation, or planning to discontinue hormone therapy during the study, as applicable.
  • Use of any prescription skin-lightening agent (such as tranexamic acid or hydroquinone), isotretinoin (or other retinoid), photo-sensitizing medication, or corticosteroid within 6 months of and during study participation.
  • History or current use of the following prescription medications:
  • Accutane or other systemic retinoids within the past twelve months;
  • Topical Retinoids within the past two weeks; and/or
  • Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix) within the past two weeks.
  • Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Laser and Skin Surgery Center of New York

    New York, New York, 10016

Other trials in United States

About this study

Official title: Evaluation of the Lutronic LaseMD System for the Treatment of Melasma

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

Read the detailed description

This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects. Subjects will receive up to 5 study treatments completed 21 days apart. Phone follow-up will occur at Day 3 following each treatment for the assessment of adverse events and expected treatment effects. Post-treatment follow-up will be completed prior to the next subsequent treatment and at Days 30, 90 and 180 following the last treatment to assess adverse events and expected treatment effects, capture digital images, and assess efficacy.

Conditions
Melasma
Being tested
LaseMD System
Medical subject headings
Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaseMD SystemDevice

    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.

Study groups in NCT03456674
Study groupRoleWhat they receive
LaseMD SystemExperimentalSubjects will receive LaseMD System treatment(s) for treatment of melasma.
Receives: Device: LaseMD System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 30 Days following the last study treatment.

Secondary outcomes (6)

  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.

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

  2. Clinician assessment of overall aesthetic improvement.

    Overall aesthetic improvement based on completion of a 5-point Clinician Global Aesthetic Improvement Scale, based on a live assessment of the subject while comparing to the subject's pre-treatment photographs, and based on a comparison of the subject's pre-treatment photographs to the current post-treatment photograph. Aesthetic improvement will be based on the following definitions:

    1. = Very Much Improved: Optimal cosmetic result.
    2. = Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal.
    3. = Improved: Obvious improvement in appearance from initial condition
    4. = No Change: The appearance is essentially the same as the original condition.
    5. = Worse: The appearance is worse than the original condition.

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

  3. Subject assessment of overall aesthetic improvement.

    Overall aesthetic improvement based on completion of a 5-point Subject Global Aesthetic Improvement Scale. Subjects will complete the scale based on a live assessment referring to a hand mirror and their pre-treatment photographs, and based on a comparison of their pre-treatment photographs to the current post-treatment photograph. Aesthetic improvement will be based on the following definitions:

    1. = Very Much Improved: Optimal cosmetic result.
    2. = Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal.
    3. = Improved: Obvious improvement in appearance from initial condition
    4. = No Change: The appearance is essentially the same as the original condition.
    5. = Worse: The appearance is worse than the original condition.

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

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

    The Melasma Quality of Life Scale assesses the effect melasma has on the quality of life of sufferers on a scale of 1 (not bothered at all) to 7 (bothered all of the time), rating the following questions:

    1. The appearance of your skin condition
    2. Frustration about your skin condition.
    3. Embarrassment about your skin condition.
    4. Feeling depressed about your skin condition.
    5. The effects of your skin condition on your interactions with other people.
    6. The effects of your skin condition on your desire to be with people.
    7. Your skin condition making it hard to show affection.
    8. Skin discoloration making you feel unattractive to others.
    9. Skin discoloration making you feel less vital or productive.
    10. Skin discoloration affecting your sense of freedom.

    Measured: From baseline to Day 30 following last treatment.

  5. Patient Satisfaction Questionnaire

    Patient satisfaction will be evaluated based on subjects' completion of a patient satisfaction questionnaire while referring to a hand mirror and their pre-treatment photographs and their Day 30 follow-up photographs. Subjects will be asked to document Yes/No as to whether they notice any improvement in how the melasma on their face looks; beyond changes to the melasma pigment specify any changes they see in the treated areas, e.g., skin texture improvement, skin tone improvement, fine lines and wrinkles improvement, etc.; characterize their level of satisfaction with study treatment based on 5 levels of satisfaction: Very satisfied, Satisfied, Slightly Satisfied, Neither Satisfied or Dissatisfied, Dissatisfied; document Yes/No if they would recommend the treatment to friends and family members.

    Measured: Day 30 following last treatment.

  6. Treatment-related pain

    During study treatments, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being the 'Worst Possible Pain'.

    Measured: For the duration of each study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start7 Feb 2018
  3. Primary completion31 May 2019 (estimated)
  4. Study completion30 Jun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single cohort of study subjects will receive study treatment.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456674
Sponsor's protocol ID
L18002
Status last verified
Mar 2019
First submitted
26 Feb 2018
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing LaseMD System in people with Melasma, run by CynosureLutronic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in the Melasma Area and Severity Index (MASI) from Baseline (time frame: From baseline to 30 Days following the last study treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03456674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.

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