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

NCT04539561 | Unknown FDA Device

• 1 other identifier: Focus-PiQo4 Pigmentation-19-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pigmentation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pigmentation

EXPERIMENTAL

Treatment of Hand Pigmentation Using PiQo4 Laser System

Device: PiQo4 Laser System

Interventions

PiQo4 Laser System DEVICE

PiQo4 Laser System for treatment of hand pigmentation

Pigmentation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Focus Medical, LLC: lead

Study Sites (1)

"Sk;N" Clinic

London, United Kingdom

RECRUITING

Central Study Contacts

Firas Al-Niaimi, MD

CONTACT

+447956147543; Firas55@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: September 7, 2020
• Study Start: September 24, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 16, 2022

Record last verified: 2021-03

Locations

GB (1)