Evaluation of IPL Treatments for Skin Lesions

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

This study is testing if Intense Pulsed Light (IPL) treatments can safely improve the appearance of different skin lesions for people who have them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Lumenis Be Ltd. (Industry-sponsored)
• Locations: 1 site (Yoqne'am 'Illit)
• Trial ID: NCT05630690 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Intense Pulsed Light (IPL) treatments for various cutaneous lesions, including vascular and pigmented lesions. Participants will undergo up to three treatments at one-month intervals, with treatment presets determined by a SMART Camera system and approved by a physician. The study will involve a thorough examination of skin and lesion attributes at each visit and follow-up, focusing on improving the appearance of the skin. The trial aims to gather data on the effectiveness of these treatments in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 21-80 with visible textural lesions on their face or décolletage.

Not a fit: Patients without visible textural lesions or those with contraindications to IPL treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a non-invasive option to improve the appearance of skin lesions.

How similar studies have performed: Previous studies have shown promising results with IPL treatments for similar skin conditions, indicating a potential for success in this approach.

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:

   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.

Where this trial is running

Yoqne'am 'Illit

• Lumenis Be Ltd. — Yoqne'am 'Illit, Israel (Recruiting)

Study contacts

• Study coordinator: Rula Masoud, PhD

Conditions Vascular Lesion; Pigmented Lesions