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 range21 Years – 80 Years

SexALL

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
✕. Active cold sores, open lacerations, or abrasions

What they're measuring

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

To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V

Timeframe: 4 months

Trial details

NCT IDNCT05755139

SponsorLumenis Be Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-23

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