Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL

A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign hand pigmentation who wish to improve their skin appearance.

Study Overview

• Status: Recruiting
• Conditions: Pigmentation
• Intervention / Treatment: Device: PiQo4 Laser System

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Firas Al-Niaimi, MD; Phone Number: +447956147543; Email: Firas55@hotmail.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • "Sk;N" Clinic
    • Contact: Firas Al-Niaimi, Dr.; Phone Number: +447956147543

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy Female/Male.
• Age= 21-70 (Adults).
• Fitzpatrick skin phototype = I-V
• Congenital or acquired benign pigmentation on hands.
• Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.
• Able to read, understand and provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.

Exclusion Criteria:

• History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
• Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.
• Excessive underlying vascular conditions (e.g. dense network of capillaries).
• Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding.
• Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study.
• Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
• Prior treatment with medium-depth or deeper, chemical peels or dermabrasion in treated area within 3 months of initial treatment or during the course of the study.
• Any other surgery in treated area within 9 months of initial treatment or during the course of the study.
• Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated.
• Multiple dysplastic nevi or suspicious pigmentation in area to be treated.
• Presence of underlying tattoo in the treatment area.
• Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pigmentation; Treatment of Hand Pigmentation Using PiQo4 Laser System	Device: PiQo4 Laser System; PiQo4 Laser System for treatment of hand pigmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hands pigmentation change assessed by investigator	Hands pigmentation change assessed by investigator at the 1 month follow up using the 5-point Pigment Improvement Score where score of between 0 and 4 will be assigned (0- No improvement in pigmentation, 1- Trace to mild improvement of some lesions, 2- Moderate response: some lesions lighter, 3- Good response: most lesions much lighter and 4- Excellent response- Most or all lesions much lighter or gone.	1 month follow up

Collaborators and Investigators

• Sponsor: Focus Medical, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 24, 2020
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (ACTUAL): September 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Focus-PiQo4 Pigmentation-19-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes