NCT02146820

Completed

Picosecond Laser for Ttreatment of Benign Pigmented Lesions

Syneron Medical Source

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Other study identifiers

Sponsor study identifier

DHF13661

Study Type

interventional

Actual enrollment (reported)

60

Locations

2 countries

Sites

2

Timeline

Study Start

December 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2015

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 60 participants
Study completion date: Not reported
Date not reported
Listed locations: 2 countries · 2 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 19, 2014
Actual (reported)
First Posted
May 26, 2014
Actual (reported)
Primary Completion
May 2015
Actual (reported)

Last Updated: June 26, 2015
Status Verified: June 2015
Last Update Submitted: June 25, 2015

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 systemDevice

Picosecond Laser System for the Treatment of Pigmented Lesions

Picosecond Laser System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Syneron Medical
Industrylead

Study Sites (2)

Laser and Cosmetic Dermatology

San Francisco, California, 94115, United States

Hong Kong Dermatology and Laser Centre

Hong Kong, China

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Shlomit Mann
Syneron Medical Ltd.
STUDY DIRECTOR

Enrollment

60 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT02800525

Comparison of Picosecond and Q-switched Laser for Benign Pigmented Lesions Treatment

Phase 4Unknown

NCT03774849

PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

Not ApplicableCompleted

NCT05096247

Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

Not ApplicableCompleted

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.

Contact the study team to confirm eligibility.

Primary Completion

May 2015

Actual (reported)

Last Updated

June 26, 2015

Record last verified: 2015-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02146820
Data provider: ClinicalTrials.gov
Source updated: 2015-06-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:33 UTC

Locations

CN(1)US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Picosecond Laser System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations