Evaluation of Safety and Efficacy of IPL Presets for Cutaneous Lesions

Evaluation of Safety and Efficacy of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL in Skin Types I-V

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.

Study Overview

• Status: Recruiting
• Conditions: Pigmented Lesions; Vascular Lesion
• Intervention / Treatment: Device: IPL with smart diagnostic handpiece

Detailed Description

Up to 20 healthy subjects, aged 21-80 years old with visible textural lesions including but not limited to Lentigines, Rosacea, and Age spots / Telangiectasia on the face or décolletage that wish to improve their skin appearance. Each patient should have at least 3 treatment areas (e.g. left cheek, right cheek, forehead, nose, chin, upper/lower décolletage) that contain at least one type of lesion.

Following the SMART Camera analysis, the system will suggest treatment presets. The physician will decide whether to use the treatment presets recommended by the AI system or modify them, based on the safety and efficacy of the suggested treatment presets.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rula Masoud, PhD; Phone Number: 0503018155; Email: rula.masoud@lumenis.com

Study Locations

• Israel
  • Yoqne'am 'Illit, Israel, 20692
    • Recruiting
    • Lumenis Be Ltd.
    • Contact: Rula Masoud; Phone Number: 0503018155; Email: rula.masoud@lumenis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy Female/Male, age 21-80
2. Fitzpatrick skin type I-V

3. Presence of visible textural lesions including but not limited to:

   1. Lentigines
   2. Age spots / Telangiectasia (Photoaging treatment)
   3. Rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)
   4. Telangiectasia
4. Patients should have at least 3 treatment areas of the following: right cheek, left cheek, forehead, nose, chin, or upper/lower décolletage.
5. Able to read, understand and provide written Informed Consent.
6. Able and willing to comply with the treatment/follow-up schedule and requirements.
7. Willing to have digital photographs taken of all of the treatment areas before, during, and after the treatment.
8. Willing to refrain from using any prescription or over-the-counter topical creams used for the treatment of veins or pigmented lesions in the treatment area during the study period.
9. Willing to protect and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher in the treatment area, every day for the duration of the study.
10. Agree not to undergo any other procedure(s) in the same treatment areas during the study.
11. Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, or abstinence) at least 1 month prior to first treatment and throughout the course of the study.

Exclusion Criteria:

1. Previous treatments in the same area/s within twelve months prior to screening.
2. Fitzpatrick skin type VI.
3. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding.
4. Exposure to the sun or artificial tanning during 3-4 weeks prior to treatment. Any remaining suntan, sunburn, or artificial tanning products.
5. Active infections in the treatment area.
6. Dysplastic nevi.
7. Significant concurrent skin conditions or any inflammatory skin conditions.
8. Active cold sores, open lacerations, or abrasions in the treatment area.
9. Chronic or cutaneous viral, fungal or bacterial diseases.
10. Treatment should not be attempted on patients with a history or concurrent condition of skin cancer or pre-cancerous lesions in the treatment area
11. Tattoos in the treatment area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IPL with smart diagnostic handpiece; Standard IPL module which has FDA clearance (K083733) for a wide range of indications including vascular and pigmented lesions. The Universal IPL handpiece (HP) operates at a spectrum of 400-1,200 nm with 7 different cut-off filters and 2 different notch filters that can be easily inserted into the handpiece to treat different conditions. The SMART Camera is a novel add-on skin diagnostic (SD) tool. The SD module includes a proprietary spectral camera embedded in a handpiece, and proprietary computer vision-based algorithms designed to process the spectral information and to determine the skin attributes and optimal treatment IPL preset.

Device: IPL with smart diagnostic handpiece; treatment with IPL following diagnostic with SMART system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the safety of the SMART IPL system platform for cutaneous lesions treatment in subjects with skin types I-V	Treatment with the SMART IPL system will be considered safe when a full treatment is completed using the recommended presets by the AI system (presets are not overruled due to safety by the physician) with no serious AEs. The overall percentage of safe treatments using the AI-recommended presets from all treatments will be calculated through study completion, an average of 3 months.	End of treatments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V	Lesions clearance evaluated by the investigator at a 1-month follow-up compared to baseline using a 5-point clearance scale.	1-month follow up

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Collaborators: Emek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LUM-ABU-SMRT-22-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No