Skintel Integration Study

Skintel Integration Study for Use With the Elite+ Laser System

The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).

Study Overview

• Status: Completed
• Conditions: Skin Type From I-VI on Non-hair Bearing Skin
• Intervention / Treatment: Device: Skintel

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

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 and older
• Able to read, understand, and sign the Informed Consent Form
• Willing and able to comply with all study requirements

Exclusion Criteria:

• Hypersensitivity to light in the near infrared wavelength region
• Sun-damaged skin (treatment contraindicated with Alex laser only)
• Unprotected sun exposure (for Alex laser within four weeks of treatment; for
• Nd:YAG laser within one week of treatment), including the use of tanning beds or
• tanning products, such as creams, lotions and sprays
• Take medication which is known to increase sensitivity to sunlight
• Seizure disorders triggered by light
• Take anticoagulants
• Take or have taken oral isotretinoin, such as Accutane®, within the last six months
• Take medication that alters the wound-healing response
• History of healing problems or history of keloid formation
• Active localized or systemic infection, or an open wound in area being treated
• Significant systemic illness or an illness localized in area being treated
• History of skin cancer or suspicious lesions
• Lupus
• Have received or are receiving or gold therapy
• Pregnancy, planning on becoming pregnant or have been pregnant recently

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Skintel	Device: Skintel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index	9 months

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Principal Investigator: Sean Doherty, MD

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CYN13-SkinTel-Elite+-01