VELOS for the Treatment of Vascular Lesions and Skin Rejuvenation

Last updated: September 5, 2018
Sponsor: Syneron Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Aging

Treatment

N/A

Clinical Study ID

NCT02468453
IH149901
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 orerythematous striae or wishes to improve skin laxity or skin firmness. In specialcases 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 andpost-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 whichwill be used, de-identified, in evaluations and may be used, de-identified, inpresentations and/or publications

  8. For female candidates - subject must be post-menopausal, or surgically sterilized, orusing a medically acceptable form of birth control during the entire course of thestudy.

Exclusion

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 oran internal defibrillator.

  3. Subject has an implant in the treated area (such as metal plates or screws) or aninjected chemical substance, including Botox and collagen injections (if the face areais 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 asrecurrent Herpes Simplex in the treated area, unless treatment is conducted followinga prophylactic regimen.

  6. Subject has a history of immunosuppression/immune deficiency disorders (including HIVinfection or AIDS) or currently using immunosuppressive medications.

  7. Having or undergoing any form of treatment for active cancer, or having a history ofskin cancer or any other cancer in the areas to be treated, including actinickeratosis, presence of malignant or pre-malignant pigmented lesions.

  8. Subject is suffering from significant concurrent illness, such as such as cardiacdisorders, diabetes (type I or II), or pertinent neurological disorders.

  9. Subject has an infection or is suffering from current or has a history of significantskin conditions in the treated area or inflammatory skin conditions, including, butnot limited to: photodermatoses, active acne, excessive skin dryness, psoriasis,eczema, rash, rosacea (particularly severe open wound stage), varicella scars, openlacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatmentcourse.

  10. Having a known anticoagulative or thromboembolic condition or taking anticoagulationmedications 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-containingagents) one week before and after each treatment session.

  12. Subject has a history of pigmentary disorders, particularly tendency for hyper- orhypo-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 ofingesting medications known to induce photosensitivity, or history of seizuredisorders due to light.

  15. Subject has undergone any surgical, light-based therapy or RF procedures in thetreatment 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 monthsof treatment or during the study (if face is treated).

  18. Having received Botox/collagen/fat injections or other methods of augmentation withinjected or implanted material in the treated area within 9 months of treatment orduring the study (if face is treated).

  19. Subject has undergone a resurfacing procedure, face lift or eyelid surgery within ayear 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 skinnourishing supplements within 2 months of treatment or during the study.

  22. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanningduring the study.

  23. Participation in a study of another device or drug within three months prior toenrollment or during the study.

  24. As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study

Study Design

Total Participants: 60
Study Start date:
July 01, 2014
Estimated Completion Date:
August 31, 2019

Study 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.

Connect with a study center

  • Scripps Clinic - Carmel Valley

    San Diego, California 92130
    United States

    Site Not Available

  • Syneron Candela Institute for Education Clinic

    Wayland, Massachusetts 01778
    United States

    Active - 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

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