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

NCT ID: NCT04539561

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2022-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pigmentation

Treatment of Hand Pigmentation Using PiQo4 Laser System

Group Type: EXPERIMENTAL

PiQo4 Laser System

Intervention Type: DEVICE

PiQo4 Laser System for treatment of hand pigmentation

Interventions

PiQo4 Laser System

PiQo4 Laser System for treatment of hand pigmentation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Focus Medical, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

"Sk;N" Clinic

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Firas Al-Niaimi, MD

Role: CONTACT

Firas55@hotmail.com

+447956147543

Facility Contacts

Firas Al-Niaimi, Dr.

Role: primary

+447956147543

Other Identifiers

Focus-PiQo4 Pigmentation-19-02

Identifier Type: -

Identifier Source: org_study_id