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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POH | Experimental | Treatment of POH Using PiQo4 Laser System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiQo4 Laser System | Device | PiQo4 Laser System for treatment of POH |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic improvement | Aesthetic improvement evaluated by the investigator at the 3-month follow up compared to baseline using a 5-point improvement scale (GAIS) where a score of between 0 and 4 will be assigned (0-Worse (The appearance is worse than the original condition.); 1- No Change (The appearance is essentially the same as the original condition); 2- Improved (Obvious improvement in appearance from initial condition, but a touch-up or re-treatment is indicated.); 3- Much improved (Marked improvement in appearance from initial condition, but not completely optimal. A touch-up would slightly improve the result.); 4 - Very much improved (Optimal result) |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetic Laser Dermatology, A West Dermatology Company | San Diego | California | 92121 | United States |
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| 3 month follow up |