Clinical trial NCT02146820: Picosecond Laser for Ttreatment of Benign Pigmented Lesions
Official title: LASER TREATMENT OF BENIGN PIGMENTED LESIONS WITH A DUAL WAVELENGTH PICOSECOND LASER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Pigmented Lesions
Keywords: Pigmented Lesions, Skin Pigment, Picosecond Laser, Syneron
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global percentage of pigment clearance
timeFrame: 3 months post the final treatment
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Laser and Cosmetic Dermatology
state: California
city: Hong Kong
country: China
facility: Hong Kong Dermatology and Laser Centre
Study officials:
affiliation: Syneron Medical Ltd.
name: Shlomit Mann
role: STUDY_DIRECTOR
References: