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OpenTrials
Completed

NCT Number: NCT05755139

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

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

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westlake Dermatology, Austin, Texas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.
  • 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:
  • Previous treatments on the same area/s at least six months prior to screening
  • 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
  • Dysplastic nevi
  • Significant concurrent skin conditions or any inflammatory skin conditions
  • Active cold sores, open lacerations, or abrasions
  • Chronic or cutaneous viral, fungal or bacterial diseases
  • Treatment should not be attempted on patients with a history or concurrent condition of skin cancer or pre-cancerous lesions in the treatment area
  • Tattoos in the areas to be treated

Treatment and study plan

IPL with smart diagnostic handpiece

Device

treatment with IPL following diagnostic with SMART system

Primary outcomes

  1. To study the safety of the suggested treatment presets as suggested by the SMART IPL system platform for cutaneous lesions in subjects with skin types I-V

    Time frame: 3 month

    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.

  2. To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V

    Time frame: 4 months

    Lesions clearance will be evaluated by the investigator at a 1-month follow-up compared to baseline using a 5-point clearance scale, when 0 is no clearance, and 4 is 76-100% clearance.

    Evaluation will be completed through study completion, an average of 4 months.

Sponsors and collaborators

Lead sponsor

Lumenis Be Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2023
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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