Overview

This trial is active, not recruiting.

Condition skin type from i-vi on non-hair bearing skin
Treatment skintel
Sponsor Cynosure, Inc.
Start date December 2013
End date September 2016
Trial size 80 participants
Trial identifier NCT02130609, CYN13-SkinTel-Elite+-01

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
skintel

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Skintel Integration Study for Use With the Elite+ Laser System
Principal investigator Sean Doherty, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Cynosure, Inc..