Skintel Integration Study
This trial is active, not recruiting.
|Condition||skin type from i-vi on non-hair bearing skin|
|Start date||December 2013|
|End date||September 2016|
|Trial size||80 participants|
|Trial identifier||NCT02130609, CYN13-SkinTel-Elite+-01|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
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
|Official title||Skintel Integration Study for Use With the Elite+ Laser System|
|Principal investigator||Sean Doherty, MD|
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