Skintel Integration Study

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skintel

Device

Primary outcomes

improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index

Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Official study title

Skintel Integration Study for Use With the Elite+ Laser System

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 5, 2014
Registry last updated: Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.