Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL

NCT ID: NCT05755139

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-04
• Study Completion Date: 2023-08-15

Brief 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

Detailed Description

At least 40 healthy subjects in 2 sites, 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 contains at least one type of lesion

Conditions

Vascular Lesion; Pigmented Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IPL with smart diagnostic handpiece

Intervention Type: DEVICE

treatment with IPL following diagnostic with SMART system

Interventions

IPL with smart diagnostic handpiece

treatment with IPL following diagnostic with SMART system

Intervention Type: DEVICE

Eligibility Criteria

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:

• Lentigines
• Rosacea (erythematotelangiectatic rosacea and papulopustular rosacea)
• Age spots/Telangiectasia
• Telangiectasia 4. Patients should have at least 3 treatment areas of the following: right cheek, left cheek, forehead, nose, chin, and 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 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 3 months prior to enrollment and throughout the course of the study.

Exclusion Criteria

• Any of the following will exclude the subject from the study:

1. Previous treatments on the same area/s at least six months prior to screening

2. 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

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 areas to be treated

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Friedmann, MD

Role: PRINCIPAL_INVESTIGATOR

Westlake dermatology

Jennifer Deaver

Role: PRINCIPAL_INVESTIGATOR

The Pearl Dermatology

Locations

Westlake Dermatology

Austin, Texas, United States

The Pearl Dermatology

Houston, Texas, United States

Countries

Israel; United States

Other Identifiers

LUM-ABU-SMRT-22-01

Identifier Type: -

Identifier Source: org_study_id