LaseMD System for the Treatment of Melasma

Description

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

Study Start Date

February, 07 2018

Estimated Completion Date

March 2019

Interventions

  • Device: LaseMD System

Study ID

LUTRONIC Corporation -- L18002

Status

Unknown

Trial ID

NCT03456674

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

10

Sponsor

LUTRONIC Corporation

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Laser and Skin Surgery Center of New York - New York, New York 50.2 miles Jennifer Moreno 212-686-7306 jmoreno@laserskinsurgery.com

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.