Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
Not Applicable
- Conditions
- Pigmentation
- Interventions
- Device: PiQo4 Laser System
- Registration Number
- NCT04539561
- Lead Sponsor
- Focus Medical, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pigmentation PiQo4 Laser System Treatment of Hand Pigmentation Using PiQo4 Laser System
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
"Sk;N" Clinic
🇬🇧London, United Kingdom