CClinicalTrials.gg
Status unknownNCT02468453Updated Sep 6, 2018

VELOS for the Treatment of Vascular Lesions and Skin Rejuvenation

An interventional study of velos in Vascular Lesions and Photoaging, sponsored by Syneron Medical. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2014, registered May 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Vascular Lesions
  • Photoaging

Keywords

  • velos
  • Vascular
  • Rejuvenation
03

In context

Lead sponsor

Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subject is a healthy Male or Female at least 18 years of age
  2. 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.
  3. Fitzpatrick Skin Type I - VI
  4. Subject must be able to read, understand and sign the Informed Consent Form
  5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
  6. Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period
  7. 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
  8. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subject is pregnant or planning to become pregnant during the study duration. Pregnancy will be assessed by question at screening.
  2. Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  3. 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).
  4. Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
  5. 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.
  6. Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
  7. 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.
  8. Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
  9. 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.
  10. 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).
  11. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
  12. Subject has a history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  13. Subject has a history of keloid scarring or of abnormal wound healing.
  14. 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.
  15. Subject has undergone any surgical, light-based therapy or RF procedures in the treatment area within 3 months of treatment or during the study.
  16. 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.
  17. Subject has undergone a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study (if face is treated).
  18. 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).
  19. Subject has undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study (if face is treated).
  20. Subject has a tattoo or permanent make-up in the treated area.
  21. Subject has systemically used retinoids, antioxidants or medical grade of skin nourishing supplements within 2 months of treatment or during the study.
  22. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  23. Participation in a study of another device or drug within three months prior to enrollment or during the study.
  24. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Cohort 1 -facial skin disorders

    Pulsed dye laser/bipolar radiofrequency (Velos) treatment of facial skin disorders including photo-damage, age spots, lentigos, solar telangiectasia and general facial telangiectasia

    Device: velos

  • Experimental
    Cohort 2 - leg veins

    Pulsed dye laser/bipolar radiofrequency (Velos) treatment of leg veins of diameter of at least 1mm, i.e., venulectasia and reticular leg veins.

    Device: velos

  • Experimental
    Cohort 3-general skin rejuvenation

    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.

    Device: velos

  • Experimental
    Cohort 4-improving skin laxity

    Velos (Bipolar radiofrequency only) treatment for improving skin laxity or skin tightness/firmness

    Device: velos

Interventions

  • Devicevelos

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 3 months after treatment

Secondary outcomes

  1. Number and severity of all complications caused by the laser will be recorded and descriptively tabulated

    Time frame: up to 3 months

  2. Subject Improvement Questionnaire

    Time frame: up to 6 months

  3. Subject assessment of comfort level associated with treatment

    Numerical Response Scale for Rating Pain (NRS)

    Time frame: day 0, afer 4 weeks, 8 weeks and 12 weeks

07

Study locations

1 of 4 sites recruiting
  • Scripps Clinic - Carmel Valley
    San Diego, California 92130, United States
    Active, not recruiting
  • Syneron Candela Institute for Education Clinic
    Wayland, Massachusetts 01778, United States
    • Meghan Murphy, BSN · Contact · 508-358-0359
    • Konika Schallen, M.D. · Principal investigator
    Recruiting
  • Zel Skin & Laser Specialists
    Edina, Minnesota 55424, United States
    Completed
  • Laser and Skin Surgery Center of New York
    New York, New York 10016, United States
    Completed
08

References and documents

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 15004818 ↗
  • Sadick 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02468453
Lead sponsor
Syneron Medical
Responsible party
Sponsor
First posted
Jun 10, 2015
Start date
Jul 1, 2014
Primary completion
Mar 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Sep 6, 2018

Study contacts

Shlomit Mann, MSc
Contact
shlomitm@syneron-candela.com
+972732442347
Shlomit Mann, MSc
study director · Syneron Medical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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