Vascular LesionsNCT02468453
VELOS for the Treatment of Vascular Lesions and Skin Rejuvenation
A study testing velos in people with Vascular Lesions and Photoaging, run by Syneron Medical at 4 sites in United States.
Trial summary
This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Lesions, Photoaging
- What is being tested?
- velos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2014to Aug 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a healthy Male or Female at least 18 years of age
- Subject has a vascular (blood vessels) and skin disorders or erythematous scars or erythematous striae or wishes to improve skin laxity or skin firmness. In special cases non-erythematous scars or non-erythematous striae may be allowed as well.
- Fitzpatrick Skin Type I - VI
- Subject must be able to read, understand and sign the Informed Consent Form
- Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
- Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period
- Subject is willing to have photographs and/or videos taken of the treated area which will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications
- For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.
Who cannot join
- Subject is pregnant or planning to become pregnant during the study duration. Pregnancy will be assessed by question at screening.
- Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance, including Botox and collagen injections (if the face area is treated).
- Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
- Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
Show all 24Show fewer
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Subject has an infection or is suffering from current or has a history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: photodermatoses, active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Subject has a history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Subject has a history of keloid scarring or of abnormal wound healing.
- Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
- Subject has undergone any surgical, light-based therapy or RF procedures in the treatment area within 3 months of treatment or during the study.
- Having undergone any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.
- Subject has undergone a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study (if face is treated).
- Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study (if face is treated).
- Subject has undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study (if face is treated).
- Subject has a tattoo or permanent make-up in the treated area.
- Subject has systemically used retinoids, antioxidants or medical grade of skin nourishing supplements within 2 months of treatment or during the study.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three months prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 1 recruiting
- Completed
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
- Completed
Laser and Skin Surgery Center of New York
New York, New York, 10016
- Active, not recruiting
Scripps Clinic - Carmel Valley
San Diego, California, 92130
- Recruiting
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, 01778
Meghan Murphy, BSN, 508-358-0359
Konika Schallen, M.D.
About this study
Official title: Multi-center, Multi-cohort, Prospective, Open-label Study of VELOS for Treatment of Vascular Skin Disorders
This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS.
Read the detailed description
The primary objective of this trial is to collect data from the use of VELOS in clinical practice under a wide range of treatment parameters variability including RF energy, laser fluence, and laser pulse duration for treating each of the vascular disorders. This will be conducted by documenting the physician selected treatment parameters, as well as the subjects' clinical clearing response, perception of improvement and sensations, through the study treatments and post-treatment(s) follow-up visits.
Optional exploratory objectives: Collection of safety and efficacy data of the Velos with DCD cooling and Velos with contact cooling. The investigator may opt to include in this study noninvasive measurements of erythema, melanin and texture (which may be performed by eg. Chromameter, Mexameter or 3D imaging), and measurements of linear vessel diameters and lesion size.
- Conditions
- Vascular Lesions, Photoaging
- Being tested
- velos
- Keywords
- velos, Vascular, Rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
velosDevice
VELOS combines 595nm pulsed dye laser energy with bipolar RF energy. The study device can deliver 0.45 to 40 ms laser pulses at a maximum of 25 J/cm2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 -facial skin disorders | Experimental | Pulsed dye laser/bipolar radiofrequency (Velos) treatment of facial skin disorders including photo-damage, age spots, lentigos, solar telangiectasia and general facial telangiectasia Receives: Device: velos |
| Cohort 2 - leg veins | Experimental | Pulsed dye laser/bipolar radiofrequency (Velos) treatment of leg veins of diameter of at least 1mm, i.e., venulectasia and reticular leg veins. Receives: Device: velos |
| Cohort 3-general skin rejuvenation | Experimental | Pulsed dye laser/bipolar radiofrequency (Velos) treatment treatment of general skin rejuvenation including Rosacea, erythematous scars (including acne), and erythematous striae (subjects enrolled in this group must have at least two of the above mentioned treatment indications. Receives: Device: velos |
| Cohort 4-improving skin laxity | Experimental | Velos (Bipolar radiofrequency only) treatment for improving skin laxity or skin tightness/firmness Receives: Device: velos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale
Measured: up to 3 months after treatment
Secondary outcomes (3)
Number and severity of all complications caused by the laser will be recorded and descriptively tabulated
Measured: up to 3 months
Subject Improvement Questionnaire
Measured: up to 6 months
Subject assessment of comfort level associated with treatment
Numerical Response Scale for Rating Pain (NRS)
Measured: day 0, afer 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start1 Jul 2014
- Primary completionMar 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular LesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Mann, MSc, Study director, Syneron Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468453
- Sponsor's protocol ID
- IH149901
- Status last verified
- Sep 2018
- First submitted
- 31 May 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sadick NS, Makino Y. Selective electro-thermolysis in aesthetic medicine: a review. Lasers Surg Med. 2004;34(2):91-7. doi: 10.1002/lsm.20013.
PubMed 15004818Sadick NS. Combination radiofrequency and light energies: electro-optical synergy technology in esthetic medicine. Dermatol Surg. 2005 Sep;31(9 Pt 2):1211-7; discussion 1217. doi: 10.1111/j.1524-4725.2005.31928.
PubMed 16176773
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Multi-cohort, Prospective, Open-label Study of VELOS for Treatment of Vascular Skin Disorders
- ClinicalTrials.gov ID
- NCT02468453
- Acronym / sponsor ID
- IH149901
- Conditions
- Vascular Lesions, Photoaging
- Keywords
- velos, Vascular, Rejuvenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- 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.
This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS.
Detailed description
The primary objective of this trial is to collect data from the use of VELOS in clinical practice under a wide range of treatment parameters variability including RF energy, laser fluence, and laser pulse duration for treating each of the vascular disorders. This will be conducted by documenting the physician selected treatment parameters, as well as the subjects' clinical clearing response, perception of improvement and sensations, through the study treatments and post-treatment(s) follow-up visits.
Optional exploratory objectives: Collection of safety and efficacy data of the Velos with DCD cooling and Velos with contact cooling. The investigator may opt to include in this study noninvasive measurements of erythema, melanin and texture (which may be performed by eg. Chromameter, Mexameter or 3D imaging), and measurements of linear vessel diameters and lesion size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 -facial skin disorders | Experimental | Device: velosPulsed dye laser/bipolar radiofrequency (Velos) treatment of facial skin disorders including photo-damage, age spots, lentigos, solar telangiectasia and general facial telangiectasia |
| Cohort 2 - leg veins | Experimental | Device: velosPulsed dye laser/bipolar radiofrequency (Velos) treatment of leg veins of diameter of at least 1mm, i.e., venulectasia and reticular leg veins. |
| Cohort 3-general skin rejuvenation | Experimental | Device: velosPulsed dye laser/bipolar radiofrequency (Velos) treatment treatment of general skin rejuvenation including Rosacea, erythematous scars (including acne), and erythematous striae (subjects enrolled in this group must have at least two of the above mentioned treatment indications. |
| Cohort 4-improving skin laxity | Experimental | Device: velosVelos (Bipolar radiofrequency only) treatment for improving skin laxity or skin tightness/firmness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is a healthy Male or Female at least 18 years of age
- Subject has a vascular (blood vessels) and skin disorders or erythematous scars or erythematous striae or wishes to improve skin laxity or skin firmness. In special cases non-erythematous scars or non-erythematous striae may be allowed as well.
- Fitzpatrick Skin Type I - VI
- Subject must be able to read, understand and sign the Informed Consent Form
- Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
Key exclusion criteria (24 listed)
- Subject is pregnant or planning to become pregnant during the study duration. Pregnancy will be assessed by question at screening.
- Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance, including Botox and collagen injections (if the face area is treated).
- Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
- Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
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 |
|---|---|---|
| velosVELOS combines 595nm pulsed dye laser energy with bipolar RF energy. The study device can deliver 0.45 to 40 ms laser pulses at a maximum of 25 J/cm2 | Device | Cohort 1 -facial skin disorders, Cohort 2 - leg veins, Cohort 3-general skin rejuvenation, Cohort 4-improving skin laxity |
Primary outcome
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale
Time frame: up to 3 months after treatment
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale
3 secondary outcomes
Number and severity of all complications caused by the laser will be recorded and descriptively tabulated
Time frame: up to 3 months
Subject Improvement Questionnaire
Time frame: up to 6 months
Subject assessment of comfort level associated with treatment
Time frame: day 0, afer 4 weeks, 8 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 15004818Sadick NS, Makino Y. Selective electro-thermolysis in aesthetic medicine: a review. Lasers Surg Med. 2004;34(2):91-7. doi: 10.1002/lsm.20013.
- Background: PubMed 16176773Sadick NS. Combination radiofrequency and light energies: electro-optical synergy technology in esthetic medicine. Dermatol Surg. 2005 Sep;31(9 Pt 2):1211-7; discussion 1217. doi: 10.1111/j.1524-4725.2005.31928.
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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.
Shlomit Mann, MSc study director
Syneron Medical
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing velos in people with Vascular Lesions and Photoaging, run by Syneron Medical at 4 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 24 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shlomit Mann, MSc (+972732442347, shlomitm@syneron-candela.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale (time frame: up to 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02468453, which also lists 2 linked publications.
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 6 Sep 2018.