Vascular LesionNCT05755139
Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL
A study testing IPL with smart diagnostic handpiece in people with Vascular Lesion and Pigmented Lesions, run by Lumenis Be Ltd. at 2 sites in United States.
Trial 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. 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2022to 15 Aug 2023
- 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
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Westlake Dermatology
Austin, Texas, 78746
The Pearl Dermatology
Houston, Texas, 77027
About this study
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
Read the 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
- 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 suggested treatment presets as suggested by the SMART IPL system platform for cutaneous lesions 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: 3 month
To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start4 Dec 2022
- Primary completion23 Jun 2023
- Study completion15 Aug 2023
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
- Model description
- Single Group Assignmen
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Friedmann, MD, Principal investigator, Westlake dermatologyJennifer Deaver, Principal investigator, The Pearl Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755139
- Sponsor's protocol ID
- LUM-ABU-SMRT-22-01
- Status last verified
- Apr 2023
- First submitted
- 29 Nov 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL
- ClinicalTrials.gov ID
- NCT05755139
- Acronym / sponsor ID
- LUM-ABU-SMRT-22-01
- Conditions
- Vascular Lesion, Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 6 Mar 2023 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignmen
| 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 (8 listed)
- 1. Healthy Female/Male, age 21-80. 2. Fitzpatrick skin type I-V. 3. Presence of visible textural lesions including but not limited to:
- 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.
Key exclusion criteria (12 listed)
- Any of the following will exclude the subject from the study:
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 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Daniel Friedmann, MD principal investigator
Westlake dermatology
Jennifer Deaver principal investigator
The Pearl Dermatology
2 sites 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 2 sites in United States.
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 8 inclusion and 12 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: finished, 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 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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.