Evaluation of Safety and Efficacy of IPL Presets for Cutaneous Lesions

Launched by LUMENIS BE LTD. · Nov 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a specific treatment using Intense Pulsed Light (IPL) technology for various skin lesions, such as vascular and pigmented lesions. Participants will receive up to three treatments, spaced one month apart, and their skin will be monitored by a special camera system and a doctor to assess the results. The trial is currently recruiting healthy men and women aged 21 to 80 who have visible skin issues like age spots, rosacea, or other textural lesions in specific areas of their face and chest.

To join the study, participants must be in good health and have certain types of skin lesions. They should not have had any similar treatments in the past year, and women of child-bearing age must use birth control. Throughout the trial, participants will need to avoid sun exposure, follow a treatment schedule, and have their pictures taken to track progress. This study aims to gather valuable information about how well this IPL treatment works and its safety for people with specific skin concerns.

Gender

ALL

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.