Skintel Integration Study
Not Applicable
Completed
- Conditions
- Skin Type From I-VI on Non-hair Bearing Skin
- Interventions
- Device: Skintel
- Registration Number
- NCT02130609
- Lead Sponsor
- Cynosure, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Skintel Skintel -
- Primary Outcome Measures
Name Time Method improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index 9 months
- Secondary Outcome Measures
Name Time Method