An interventional study of LaseMD System in Melasma, sponsored by LUTRONIC Corporation. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by LUTRONIC Corporation (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment
This study will evaluate the clinical outcomes associated with use of the LaseMD Laser System for the treatment of melasma.
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.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →LUTRONIC Corporation is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
First submitted before LUTRONIC Corporation became part of Cynosure Lutronic, Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History or current use of the following prescription medications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive LaseMD System treatment(s) for treatment of melasma.
Device: LaseMD System
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.
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.
Time frame: From baseline to 30 Days following the last study treatment.
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.
Time frame: From baseline to Days 90 and 180 following the last study treatment.
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.
Time frame: From baseline to Days 30, 90 and 180 following last treatment.
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.
Time frame: From baseline to Days 30, 90 and 180 following last treatment.
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.
Time frame: From baseline to Day 30 following last treatment.
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.
Time frame: Day 30 following last treatment.
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'.
Time frame: For the duration of each study treatment
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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