Picosecond Laser for Ttreatment of Benign Pigmented Lesions

NCT ID: NCT02146820

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31

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.

Conditions

Benign Pigmented Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Picosecond Laser System

Group Type: EXPERIMENTAL

GentleMax system

Intervention Type: DEVICE

Picosecond Laser System for the Treatment of Pigmented Lesions

Interventions

GentleMax system

Picosecond Laser System for the Treatment of Pigmented Lesions

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shlomit Mann

Role: STUDY_DIRECTOR

Syneron Medical Ltd.

Locations

Laser and Cosmetic Dermatology

San Francisco, California, United States

Hong Kong Dermatology and Laser Centre

Hong Kong, , China

Countries

United States; China

Other Identifiers

DHF13661

Identifier Type: -

Identifier Source: org_study_id