Clinical trial NCT04539561: Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
Official title: Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pigmentation
Lead sponsor: Focus Medical, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hands pigmentation change assessed by investigator
timeFrame: 1 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: "Sk;N" Clinic
Study officials:
References: