Clinical trial NCT03456674: LaseMD System for the Treatment of Melasma
Official title: Evaluation of the Lutronic LaseMD System for the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Melasma
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort of study subjects will receive study treatment.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Female, age 18 years and older.
2. Subject in good health.
3. Fitzpatrick Skin Type I to IV.
4. Moderate to severe melasma (Melasma Severity Scale, score 2 or 3).
5. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
6. 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.
7. 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.
8. Absence of physical or psychological conditions unacceptable to the investigator.
9. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
10. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion Criteria:

1. Inability to understand the protocol or to give informed consent.
2. Presence of an active systemic or local skin disease that may affect wound healing.
3. History of keloids or poor wound healing.
4. Significant scarring in the area(s) to be treated that would interfere with assessing results.
5. Open wounds or lesions in the area(s) to be treated.
6. Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
7. History of chronic drug or alcohol abuse.
8. History of collagen vascular disease.
9. History of autoimmune disease.
10. Subjects with sensitivity or allergy to pre-treatment medication, EMLA Cream (Lidocaine/Prilocaine).
11. Subjects with sensitivity or allergy to post-treatment cosmeceuticals, Tranexamic Acid and/or coconut.
12. Subjects with photosensitive skin.
13. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
14. Subjects who are pregnant or lactating or anticipate becoming pregnant during the study.
15. Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
16. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
17. Concurrent enrollment in any study involving the use of investigational devices or drugs.
18. Current smoker or history of smoking in the last five years.
19. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
20. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
21. History of surgical or cosmetic treatments in the area(s) to be treated within the past 6 months.
22. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study.
23. 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.
24. 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.
25. History or current use of the following prescription medications:

    1. Accutane or other systemic retinoids within the past twelve months;
    2. Topical Retinoids within the past two weeks; and/or
    3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix) within the past two weeks.
    4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Primary outcomes:
measure: Improvement in the Melasma Area and Severity Index (MASI) from Baseline
timeFrame: From baseline to 30 Days following the last study treatment.
Secondary outcomes:
measure: Improvement in the Melasma Area and Severity Index (MASI) from Baseline
timeFrame: From baseline to Days 90 and 180 following the last study treatment.
measure: Clinician assessment of overall aesthetic improvement.
timeFrame: From baseline to Days 30, 90 and 180 following last treatment.
measure: Subject assessment of overall aesthetic improvement.
timeFrame: From baseline to Days 30, 90 and 180 following last treatment.
measure: Improvement in the Melasma Quality of Life Scale (MELASQOL) from baseline
timeFrame: From baseline to Day 30 following last treatment.
measure: Patient Satisfaction Questionnaire
timeFrame: Day 30 following last treatment.
measure: Treatment-related pain
timeFrame: For the duration of each study treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
Study officials:
affiliation: Sponsor GmbH
name: Kari Larson, MBA
role: STUDY_DIRECTOR
References: