Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL (NCT05755139) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL
United States60 participantsStarted 2022-12-04
Plain-language summary
Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the treatment. Skin and lesion attributes will be examined by the SMART system and the physician
Who can participate
Age range
21 Years – 80 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.
Exclusion criteria
. Previous treatments on the same area/s at least six months prior to screening
. Skin type VI
. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
. Exposure to the sun or artificial tanning during 3-4 weeks prior to treatment. Any remaining suntan, sunburn, or artificial tanning products.
. Active infections in the treatment area
. Dysplastic nevi
. Significant concurrent skin conditions or any inflammatory skin conditions
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
To study the safety of the suggested treatment presets as suggested by the SMART IPL system platform for cutaneous lesions in subjects with skin types I-V
Timeframe: 3 month
2
To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V