Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pigmentation Treatment of Hand Pigmentation Using PiQo4 Laser System |
Device: PiQo4 Laser System
PiQo4 Laser System for treatment of hand pigmentation
|
Outcome Measures
Primary Outcome Measures
- Hands pigmentation change assessed by investigator [1 month follow up]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy Female/Male.
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Age= 21-70 (Adults).
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Fitzpatrick skin phototype = I-V
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Congenital or acquired benign pigmentation on hands.
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Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.
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Able to read, understand and provide written Informed Consent.
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Able and willing to comply with the treatment/follow-up schedule and requirements.
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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:
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History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
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Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.
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Excessive underlying vascular conditions (e.g. dense network of capillaries).
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Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding.
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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.
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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.
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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.
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Any other surgery in treated area within 9 months of initial treatment or during the course of the study.
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Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated.
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Multiple dysplastic nevi or suspicious pigmentation in area to be treated.
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Presence of underlying tattoo in the treatment area.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | "Sk;N" Clinic | London | United Kingdom |
Sponsors and Collaborators
- Focus Medical, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Focus-PiQo4 Pigmentation-19-02