Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT04539561
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT04539561
Study Brief:
Protocol Section:
NCT04539561