Lutronic LaseMD for Treatment of Benign Pigmented Lesions

Completed · Not applicable

Conditions studied: Benign Pigmented Lesions

In brief

The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.

Key facts

Study ID

NCT03409952

Run by

CynosureLutronic

People needed

20

Starts

2017-11-17

Expected to finish

2019-02-25

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to VI.
• Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
• 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.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries; or
• Bilateral tubal ligation at least six months prior to study enrollment.
• 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.

You may not qualify if…

• 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.
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
• 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 implanted pacemaker or defibrillator.
• Subjects with sensitivity or allergy to gold.
• Subjects with sensitivity or allergy to benzocaine, lidocaine, ortetracaine.
• 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.,ecigarettes, Nicorette gum, nicotine patches,etc.
• History of surgical or cosmetic treatments in the area(s) to be treated within the past 6 months.
• 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

Where it is running

• Maryland Dermatology Laser, Skin & Vein Institute — Hunt Valley, Maryland, United States
• Dermatology, Laser, and Vein Specialists of the Carolinas — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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