Skintel Integration Study | NCT02130609

Studies
Skintel Integration Study

NCT02130609

Sponsor

Cynosure, Inc.

Status

Completed

Last Update Posted

Oct 28, 2020Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Skin Type From I-VI on Non-hair Bearing Skin

Interventions

Skintel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2020

Last Update Posted Date

Oct 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
Skintel	Experimental		Device: Skintel

Name	Type	Description	Arm Group Labels	Other Names
Skintel	Device		Skintel

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sean Doherty, MD		Principal Investigator

Intervention Model Description

Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial. 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).