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Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

NCT04202419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-07

Study results available
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Summary

This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).

Conditions

  • Pigmented Skin Lesion

Interventions

DEVICE

FRAX 1940 nm laser

A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.

Sponsors & Collaborators

  • Miami Dermatology and Laser Institute

    collaborator OTHER

  • Candela Corporation

    lead INDUSTRY

Principal Investigators

  • Jill S Waibel, M.D · Miami Dermatology and Laser Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2021-04-26
Completion
2021-04-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202419 on ClinicalTrials.gov