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Efficacy and Safety of PiQo4 Device for Treatment of Melasma

NCT03565341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-27

No results posted yet for this study

Summary

Single center, Prospective, Open Label with Split-face Study Design. Face sides will be randomized to receive either 1064nm alone or 1064nm \& 585nm combination treatment.

Each subject will receive up to 3 treatments at monthly intervals (±4 days). Follow-up visits will take place at 1, 3, and 6 months following the last treatment.

Conditions

  • Melasma

Interventions

DEVICE

PiQo4

PiQo4 Laser System for treatment of Melasma

Sponsors & Collaborators

  • Focus Medical, LLC

    lead INDUSTRY

Principal Investigators

  • David J Goldberg, MD · Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2019-08-08
Completion
2019-08-08
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 NCT03565341 on ClinicalTrials.gov