Vascular LesionNCT05630690
Evaluation of Safety and Efficacy of IPL Presets for Cutaneous Lesions
A study testing IPL with smart diagnostic handpiece in people with Vascular Lesion and Pigmented Lesions, run by Lumenis Be Ltd. at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Lesion, Pigmented Lesions
- What is being tested?
- IPL with smart diagnostic handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Oct 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Female/Male, age 21-80
- Fitzpatrick skin type I-V
- Presence of visible textural lesions including but not limited to:
- Lentigines
- Age spots / Telangiectasia (Photoaging treatment)
- Rosacea (Erythematotelangiectatic rosacea and papulopustular rosacea)
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- Telangiectasia
- Patients should have at least 3 treatment areas of the following: right cheek, left cheek, forehead, nose, chin, or upper/lower décolletage.
- Able to read, understand and provide written Informed Consent.
- 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 the treatment.
- 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.
- 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 1 month prior to first treatment and throughout the course of the study.
Who cannot join
- Previous treatments in the same area/s within twelve months prior to screening.
- Fitzpatrick 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.
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- Significant concurrent skin conditions or any inflammatory skin conditions.
- Active cold sores, open lacerations, or abrasions in the treatment area.
- 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 treatment area.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lumenis Be Ltd.
Yokneam Illit, 20692
Rula Masoud, 0503018155, rula.masoud@lumenis.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Vascular Lesion, Pigmented Lesions
- Being tested
- IPL with smart diagnostic handpiece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL with smart diagnostic handpieceDevice
treatment with IPL following diagnostic with SMART system
| Study group | Role | What they receive |
|---|---|---|
| IPL with smart diagnostic handpiece | Experimental | 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. Receives: Device: IPL with smart diagnostic handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatments
Secondary outcomes (1)
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.
Measured: 1-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start4 Oct 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emek Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630690
- Sponsor's protocol ID
- LUM-ABU-SMRT-22-02
- Status last verified
- Dec 2023
- First submitted
- 19 Sep 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL in Skin Types I-V
- ClinicalTrials.gov ID
- NCT05630690
- Acronym / sponsor ID
- LUM-ABU-SMRT-22-02
- Conditions
- Vascular Lesion, Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Emek Medical Center
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPL with smart diagnostic handpiece | Experimental | Device: IPL with smart diagnostic handpieceStandard 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy Female/Male, age 21-80
- Fitzpatrick skin type I-V
- Presence of visible textural lesions including but not limited to:
- Patients should have at least 3 treatment areas of the following: right cheek, left cheek, forehead, nose, chin, or upper/lower décolletage.
- Able to read, understand and provide written Informed Consent.
Key exclusion criteria (11 listed)
- Previous treatments in the same area/s within twelve months prior to screening.
- Fitzpatrick 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPL with smart diagnostic handpiecetreatment with IPL following diagnostic with SMART system | Device | IPL with smart diagnostic handpiece |
Primary outcome
To study the safety of the SMART IPL system platform for cutaneous lesions treatment in subjects with skin types I-V
Time frame: End of treatments
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.
1 secondary outcome
To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V
Time frame: 1-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL with smart diagnostic handpiece in people with Vascular Lesion and Pigmented Lesions, run by Lumenis Be Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rula Masoud, PhD (0503018155, rula.masoud@lumenis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the safety of the SMART IPL system platform for cutaneous lesions treatment in subjects with skin types I-V (time frame: End of treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.