VELOS for the Treatment of Vascular Lesions and Skin Rejuvenation

NCT02468453 | Unknown

• 1 other identifier: IH149901
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Vascular Lesions; Photoaging

Keywords

velos; Vascular; Rejuvenation

Outcome Measures

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

  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

  up to 3 months

• Subject Improvement Questionnaire

  up to 6 months

• Subject assessment of comfort level associated with treatment

  day 0, afer 4 weeks, 8 weeks and 12 weeks

Study Arms (4)

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

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.

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.

Device: velos

Cohort 4-improving skin laxity

EXPERIMENTAL

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

Device: velos

Interventions

velos DEVICE

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

Cohort 1 -facial skin disorders; Cohort 2 - leg veins; Cohort 3-general skin rejuvenation; Cohort 4-improving skin laxity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (4)

Scripps Clinic - Carmel Valley

San Diego, California, 92130, United States

ACTIVE NOT RECRUITING

Syneron Candela Institute for Education Clinic

Wayland, Massachusetts, 01778, United States

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

Related Publications (2)

• 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.

  PMID: 15004818 BACKGROUND

• 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.

  PMID: 16176773 BACKGROUND

Study Officials

• Shlomit Mann, MSc

  Syneron Medical

  STUDY DIRECTOR

Central Study Contacts

Shlomit Mann, MSc

CONTACT

+972732442347; shlomitm@syneron-candela.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 10, 2015
• Study Start: July 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

US (4)