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Skintel Integration Study

NCT ID: NCT02130609

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Skintel

Group Type EXPERIMENTAL

Skintel

Intervention Type DEVICE

Interventions

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Skintel

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cynosure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Doherty, MD

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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CYN13-SkinTel-Elite+-01

Identifier Type: -

Identifier Source: org_study_id