NCT04208100

Active Not Recruiting

Pilot Evaluation of the Lutronic PicoPlus System for the Tre...

CynosureLutronic Source

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Other study identifiers

Sponsor study identifier

L18007

Study Type

interventional

Actual enrollment (reported)

41

Locations

1 country

Sites

1

Timeline

Study Start

September 13, 2018

Actual (reported)

Primary Completion

September 5, 2019

Actual (reported)

Study Completion

March 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated.

Registry Overview

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

Recruitment status: active not recruiting
Actual enrollment (reported): 41 participants
Study completion date: March 31, 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

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
September 13, 2018
Actual (reported)
Primary Completion
September 5, 2019
Actual (reported)
First Submitted
December 17, 2019
Actual (reported)
First Posted
December 23, 2019
Actual (reported)
Study Completion
March 31, 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: December 24, 2019
Status Verified: December 2019
Last Update Submitted: December 20, 2019

Conditions

Benign Pigmented Lesions

Outcome Measures

Primary Outcomes (1)

Pigmentary Clearance
Percentage of pigmentary clearance by each wavelength in standard photographs from the 30-day visit post the last treatment in Phase I of the study using a score of 0-4, representing poor 0-24%, fair 25-49%, good 50-74%, excellent 75-95%, and complete 95%+ improvement was given at the day 30 follow-up visit post the last treatment as determined by three blinded physician evaluators comparing the baseline vs 30-day follow-up visit photographs.
30 days

Secondary Outcomes (2)

Clinician Global Aesthetic Scale
30 days
Subject Global Aesthetic Scale
30 days

Other Outcomes (2)

Patient Satisfaction Questionnaire
30 days
Pain Scale
30 days

Interventions

PicoPlusDevice

The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 595nm and 660nm wavelengths of the Lutronic PicoPlus Laser system are used for the treatment of benign pigmented lesions.

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age 18 years and older.
Subject in good health.

Sponsors & Collaborators

CynosureLutronic
Industrylead

Study Sites (1)

William LoVerme, MD

Billerica, Massachusetts, 01821, United States

Enrollment

41 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 23, 2019

Study Start

September 13, 2018

Actual (reported)

NCT03774849

PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

Not ApplicableCompleted

NCT04207047

Histologic Evaluation of Tissue Following Lutronic System Exposure

Not ApplicableUnknown

NCT02800525

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

Phase 4Unknown

NCT05096247

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

Not ApplicableCompleted

Fitzpatrick Skin Type I to IV.

Presence of benign pigmented lesions on hands.

Understands and accepts the obligation not to undergo any other procedures in the treatment area.

Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:

Postmenopausal for at least 12 months prior to study;

Without a uterus and/or both ovaries; or

Bilateral tubal ligation at least six months prior to study enrollment.

Absence of physical or psychological conditions unacceptable to the investigator.

Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if:

Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, or chemotherapy.
Subjects with a history of photosensitivity or diseases which may be stimulated by light at the wavelengths used, such as history of systemic Lupus Erythematosus, Pophyia, and Epilepsy.
History of chronic drug or alcohol abuse.
Inability to understand the protocol or to give informed consent.
Subjects with a history of skin cancer or current condition of any other type of cancer or pre-malignant moles.
Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
History of keloid formation.
Subjects with tattoos on the backs of the hands in the treatment area.
History of surgical or cosmetic treatments in exposure area within the past six months.
History of tanning or use of self-tanners in the past 4 weeks.
History of treatments that may irritate the skin in the treatment area such as depilatories, harsh chemicals, etc.) in the past 2 weeks.

Contact the study team to confirm eligibility.

Primary Completion

September 5, 2019

Actual (reported)

Study Completion

March 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

December 24, 2019

Record last verified: 2019-12

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: NCT04208100
Data provider: ClinicalTrials.gov
Source updated: 2019-12-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:54 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations