Picosecond Laser for Ttreatment of Benign Pigmented Lesions

Benign Pigmented Lesions Clinical Trial

Official title:

LASER TREATMENT OF BENIGN PIGMENTED LESIONS WITH A DUAL WAVELENGTH PICOSECOND LASER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146820
• Other study ID #: DHF13661
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: June 25, 2015
• Start date: December 2013

Study information

• Verified date: June 2015
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Pigmented Lesions

Intervention

Device:
• GentleMax system
Picosecond Laser System for the Treatment of Pigmented Lesions

Locations

Country	Name	City	State
China	Hong Kong Dermatology and Laser Centre	Hong Kong
United States	Laser and Cosmetic Dermatology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants with Adverse Events	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.	3 months	Yes