Lutronic LaseMD for Treatment of Benign Pigmented Lesions (NCT03409952) | Clinical Trial Compass
CompletedNot Applicable
Lutronic LaseMD for Treatment of Benign Pigmented Lesions
United States20 participantsStarted 2017-11-17
Plain-language summary
The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Group A: Evaluation of split-side pigmentary clearance
Timeframe: 90 days following the last study treatment
2
Group B: Percentage of pigmentary clearance in standard photographs
Timeframe: 90 days following the last study treatment
. 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).
0. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
. Presence of an active systemic or local skin disease that may affect wound healing.