Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions (NCT04203745) | Clinical Trial Compass
CompletedNot Applicable
Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions
United States26 participantsStarted 2019-09-18
Plain-language summary
This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.
Who can participate
Age range
21 Years – 70 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 21 to 70
. Fitzpatrick Skin Type I to V
. Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
. Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff
. Provide signed informed consent to participate in the study
. Adhere to study treatment and follow-up schedules
. Willing to have hair removed from the intended treatment area prior to treatment and/or photography
Exclusion criteria
. Pregnant, planning to become pregnant, or breast feeding during the study
. Allergy to lidocaine or similar medications
. Excessively tanned skin in the intended treatment area
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
Pigmented Lesion Improvement by Blinded Evaluation
Timeframe: 1 month follow-up post treatment series, where treatment could last up to 10 weeks from baseline