Status:
ACTIVE_NOT_RECRUITING
LaseMD System for the Treatment of Melasma
Lead Sponsor:
LUTRONIC Corporation
Conditions:
Melasma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03456674
Start Date
February 7 2018
End Date
June 30 2019
Last Update
March 13 2019
Active Locations (1)
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1
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016