Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions

Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
United States
Maryland
Maryland Dermatology Laser, Skin & Vein Institute
Hunt Valley
North Carolina
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte
Time Frame
Start Date: 2017-11-17
Completion Date: 2019-02-25
Participants
Target number of participants: 20
Treatments
Active_comparator: Group A: LaseMD and DUAL 1927nm Laser
Group A subjects will receive split-side study treatments comparing two devices: LaseMD compared to the DUAL 1927nm laser.
Active_comparator: Group B: LaseMD Optimized
Group B subjects will receive LaseMD Optimized Treatments based on Group A treatment data.
Sponsors
Leads: LUTRONIC Corporation

This content was sourced from clinicaltrials.gov