Evaluation of the Efficacy and Safety of PiQo4 System for the Treatment of Pigmented Lesions

NCT03565146 | Completed FDA Device

• 1 other identifier: Focus-PiQo4 Pigmentation-17-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A total of at least 25 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign facial pigmentation with or without hand pigmentation who wish to improve their skin appearance.

Conditions

Pigmentation

Outcome Measures

Primary Outcomes (1)

• Pigmentation Improvement Scale

  Facial Pigmentation Improvement evaluated by the investigator at the 1 month follow up visit compared to baseline using a 5-point improvement scale where a score of between 0 and 4 will be assigned (0-No improvement; 1- Trace to mild improvement of some lesions; 2- Moderate response: some lesions lighter; 3- Good response: most lesions much lighter; 4 - excellent response: most or all lesions are much lighter or gone)

  1 month follow up

Secondary Outcomes (1)

• Pigmentation Improvement Scale

  3 month follow up

Study Arms (1)

Pigmentation

EXPERIMENTAL

Treatment of Pigmented Lesions Using PiQo4 Laser System

Device: PiQo4 Laser System

Interventions

PiQo4 Laser System DEVICE

PiQo4 Laser System for treatment of pigmented lesions

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 or Male
• Age= 21-70 (Adults)
• Fitzpatrick skin phototype = I-V
• Congenital or acquired benign pigmentation on face with optional pigmentation on hand.
• Presence of at least 4 lesions of 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
• Willing to have digital photographs taken of the treatment area
• Willing to refrain from using any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, retinoids, and/or corticosteroids) in the treatment area during the study period.
• Willing to protect from sun exposure and use an approved sunscreen of SPF 30 or higher in the treatment area daily during the entire duration of the study, including the follow-up period.
• Agree not to undergo any other procedure(s) for the treatment of pigmentation or solar lentigines during the study.

You may not qualify if:

• History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation
• Melasma
• 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 or face-lift 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
• Prior use of any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, retinoids, and/or corticosteroids) in the treatment 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 in area to be treated
• 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
• Any dermal/epidermal damage or disorder, mainly vascular or textural lesions, in the treatment area.
• Any underlying tattoo in the treatment area.
• Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study

Sponsors & Collaborators

• Focus Medical, LLC: lead

Study Sites (1)

Westlake Dermatology

Austin, Texas, 78746, United States

Location

Study Officials

• Daniel P Friedmann

  Westlake Dermatology

  PRINCIPAL INVESTIGATOR

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: June 10, 2018
• First Posted: June 21, 2018
• Study Start: June 29, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: December 27, 2019

Record last verified: 2018-06

Locations

US (1)