Cosmetic Dermatology Study

Evaluation of VeinViewer in Cosmetic Dermatology

This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures.

Study Overview

• Status: Completed
• Conditions: Cosmetic Procedures
• Intervention / Treatment: Device: VeinViewer

Detailed Description

This study was designed as an observational study to determine if VeinViewer technology helped to improve the efficiency of certain dermatological procedures namely botox injections and schlerotherapy for varicose veins. The device was used to identify veins but clinical decisions were ultimately left the physician.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92121
      • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • MD Laser Skin & Vein Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and up
• Male or Female
• Receiving cosmetic dermatological injection
• Willing to participate

Exclusion Criteria:

• Aged younger than 18 years
• Prior history of known light sensitivity
• Other reasons as determined by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VeinViewer; VeinViewer will be used in conjunction with routine cosmetic dermatology procedures. Patients and physicians will complete questionnaires.	Device: VeinViewer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient perception of the use of the device	Small questionnaires will be used to assess how the patient perceives the use of the device (i.e., did the patient have a positive attitude towards the device?)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician perception of the use of the device	Physicians will complete a small questionnaire to understand what their perception of the use of the device to be (i.e, did the physician have a positive attitude towards the device while using it).	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of adverse events related to the standard of care procedure	VeinViewer may be used to detect adverse events related to the standard of care procedure (e.g., bruising).	2nd day

Collaborators and Investigators

• Sponsor: Christie Medical Holdings, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cosmetic dermatology; near-infrared; patient preference; physician preference
• Other Study ID Numbers: SPN - 13 / 04 - 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No