Evaluation of the Effectiveness of the PiQo4 System for Reduction of Infra-orbital Pigmentation

NCT04214873 | Completed FDA Device

• 1 other identifier: Focus-PiQo4 POH-19-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 10 healthy subjects at a single site, aged 18-65 years old and Fitzpatrick skin type I-IV with mild to moderate infra-orbital hyperpigmentation on the background of epidermal and/or dermal pigmentation that wish to improve their POH

Conditions

POH

Outcome Measures

Primary Outcomes (1)

• Change in POH severity

  POH improvement of at least 1 point evaluated by the investigator at the 3-month follow up compared to baseline using the POH severity in comparison to surrounding skin scale where score of between 0 and 4 will be assigned (0-Normal (Skin color comparable to other facial skin areas); 1- Trace (Faint pigmentation of infraorbital fold (bilateral)); 2- Mild (Pigmentation more pronounced); 3- Moderate (Deep dark colour, all four lids involved): ; 4 - Marked (Grade 3 + pigmentation spreading beyond infraorbital fold)

  3 month follow up

Secondary Outcomes (1)

• Aesthetic improvement

  3 month follow up

Study Arms (1)

POH

EXPERIMENTAL

Treatment of POH Using PiQo4 Laser System

Device: PiQo4 Laser System

Interventions

PiQo4 Laser System DEVICE

PiQo4 Laser System for treatment of POH

POH

Eligibility Criteria

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

You may qualify if:

• Females or males
• Age 18-65
• Fitzpatrick skin types I-IV
• POH on the background of epidermal and/or dermal pigmentation
• POH severity - mild to moderate
• Able to read, understand and provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and post treatment care
• Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period)
• Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions
• Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions
• Agreed to have their face photographed and willingness to allow Focus Medical (the study Sponsor) and Lumenis and the investigators to use de-identified photographs of the treated area for presentation and publication purposes
• Women of childrearing potential (not postmenopausal \[no menstrual cycle for at least 12 months\], without an uterus and/or both ovaries, or has had a bilateral tubal ligation)
• \*(In case of women of childbearing potential) Tested negative in the pregnancy test and agreed to use birth control measures during the clinical trial period including use of contraceptives (see list below) IUD, Double-Barrier Method, Vasectomized Partner, No Heterosexual Intercourse, etc
• Agreed not to undergo any other procedure on their face during their participation in the clinical trial

You may not qualify if:

• Pregnant or breastfeeding
• Inability to comply with all study protocols and regulations
• Participation in a study of another device or drug
• Heavy smokers and/or drinkers (those who smoke 25 or more cigarettes a day and/or ⩾8 drinks a week for women, and ⩾15 for men)
• Application of any energy device treatment to the infraorbital region within 3 months
• Application of any dermal filler to the infraorbital region within 6 months
• Facial resurfacing, deep chemical peels, or taking oral retinoids within 6 months
• Microdermabrasion (light or medium skin peel) treatment within 30 days
• Chemical peel, systemic steroids, non-ablative laser, light, or radiofrequency treatment within 3 months
• Use of topical lightening agents or retinoids within 14 days
• Any planned surgical intervention to the face for the duration of the trial
• Use of Latisse, Revitalash, or other lash enhancement stimulators as well as Bimatoprost in the previous 1 month
• Presence of open wounds, lesions, or scarring in the area
• Very thin skin (skin that tears, bruises, or breaks easily)
• Suffering from current or history of significant skin conditions in the treated area that could interfere with the evaluation (i.e. infection, dermatitis, or rash on their face) or requires the use of interfering topical or systemic therapy.

Sponsors & Collaborators

• Focus Medical, LLC: lead

Study Sites (1)

Cosmetic Laser Dermatology, A West Dermatology Company

San Diego, California, 92121, United States

Location

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: December 25, 2019
• First Posted: January 2, 2020
• Study Start: January 6, 2020
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: October 3, 2023

Record last verified: 2022-01

Locations

US (1)