Skintel Integration Study

Cynosure

Status

Completed

Conditions

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

Treatments

Device: Skintel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02130609

CYN13-SkinTel-Elite+-01

Details and patient eligibility

About

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).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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