Evaluation of Safety and Efficacy of IPL Presets for Cutaneous Lesions (NCT05630690) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Safety and Efficacy of IPL Presets for Cutaneous Lesions
Israel20 participantsStarted 2023-10-04
Plain-language summary
Single-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive up to three (3) consecutive treatments at 1-month interval. 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 last treatment. Skin and lesion attributes will be examined by the SMART system and the physician on each visit and at follow-up.
Who can participate
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy Female/Male, age 21-80
✓. Fitzpatrick skin type I-V
✓. Presence of visible textural lesions including but not limited to:
✓. Lentigines
✓. Age spots / Telangiectasia (Photoaging treatment)
✓. Rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)
✕. Previous treatments in the same area/s within twelve months prior to screening.
✕. Fitzpatrick 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.
✕
What they're measuring
1
To study the safety of the SMART IPL system platform for cutaneous lesions treatment in subjects with skin types I-V