Picosecond Laser for Ttreatment of Benign Pigmented Lesions

NCT02146820 | Completed

• 1 other identifier: DHF13661
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.

Conditions

Benign Pigmented Lesions

Keywords

Pigmented Lesions, Skin Pigment, Picosecond Laser, Syneron

Outcome Measures

Primary Outcomes (1)

• Global percentage of pigment clearance

  Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.

  3 months post the final treatment

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  3 months

Study Arms (1)

Picosecond Laser System

EXPERIMENTAL

Device: GentleMax system

Interventions

GentleMax system DEVICE

Picosecond Laser System for the Treatment of Pigmented Lesions

Picosecond Laser System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has Fitzpatrick skin type I-VI
• 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
• Is willing to sign an informed consent form to participate in the study
• 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

You may not qualify if:

• Is hypersensitive to light exposure
• Has an active sun tan
• Has active localized or systemic infection
• Is taking medication(s) for which sunlight is a contraindication
• Has a history of squamous cell carcinoma or melanoma
• Has a history of keloid scarring
• 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.
• Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
• Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
• Is female and pregnant is currently breast feeding or planning a pregnancy during the study period
• Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine
• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (2)

Laser and Cosmetic Dermatology

San Francisco, California, 94115, United States

Location

Hong Kong Dermatology and Laser Centre

Hong Kong, China

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shlomit Mann

  Syneron Medical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (1); CN (1)