Benign Pigmented Lesions
Conditions
Keywords
Pigmented Lesions, Skin Pigment, Picosecond Laser, Syneron
Brief summary
The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.
Detailed description
The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.
Interventions
DEVICEGentleMax system
Picosecond Laser System for the Treatment of Pigmented Lesions
Sponsors
Syneron Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Has Fitzpatrick skin type I-VI 2. Has unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, New of Ota, Nevus of Ito, and hyperpigmentation, and wishes to undergo laser treatments to remove them 3. Is willing to sign an informed consent form to participate in the study 4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
Exclusion criteria
1. Is hypersensitive to light exposure 2. Has an active sun tan 3. Has active localized or systemic infection 4. Is taking medication(s) for which sunlight is a contraindication 5. Has a history of squamous cell carcinoma or melanoma 6. Has a history of keloid scarring 7. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness. 8. Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months 9. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications 10. Is female and pregnant is currently breast feeding or planning a pregnancy during the study period 11. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine 12. Subjects with pigmented lesions that are considered not acceptable by the study doctor or any condition that, in the study doctor's opinion, would make it unsafe to treat.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global percentage of pigment clearance | 3 months post the final treatment | Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | 3 months | Adverse events will be evaluated immediately after and before each subsequent laser treatment and will be based on the incidence and severity of side effects caused by the laser treatments. |
Countries
China, United States
Outcome results
None listed