Eligibility Details:
Inclusion Criteria:
- Healthy male or female, 18 years or older
- Fitzpatrick skin type I-V
- Has visible signs of moderate to severe skin pigmentation
- Subject must agree to not make any changes in their skin regimen for the duration of
the study, including the follow-up period
- Subject must be able to read, understand and sign Informed Consent Form
- Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes
- Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or
higher on the treatment area every day for the duration of the study, including the
follow-up period
- Must be willing to adhere to the treatment and follow-up schedule and post-treatment
care instructions
- Agree to not use any other procedure(s) in the treatment area during the study, such
as laser- or light-based treatment, non-light based device treatment such as
radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid
filler or other dermal filler, chemical peel, or surgical procedure
- Post-menopausal or surgically sterilized, or using a medically acceptable form of
birth control at least 3 months prior to enrollment and during the entire course of
the study, and no plans to become pregnant or to father a child for the duration of
the study
Exclusion Criteria:
- Participation in a clinical trial of another device or drug within 6 months prior to
enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 3 months of study
participation, such as laser or light-based procedures or surgery.
- Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal
filler in the target area within 1 week of study participation.
- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large
moles.
- Pregnant and/or breastfeeding.
- Having an infection, dermatitis or a rash in the treatment area.
- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,
e.g., uncontrolled hypertension.
- Suffering from coagulation disorders or taking prescription anticoagulation
medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications.
- History of vitiligo, eczema, or psoriasis.
- History of connective tissue disease, such as systemic lupus erythematosus or
scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to
Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes
zoster (shingles) in the treatment area, unless treatment is conducted following a
prophylactic regimen.
- History of radiation to the treatment area or undergoing systemic chemotherapy for the
treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-
pigmentation.
- Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable,
within 6 months of study participation.
- Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the
target area within 1 month of participation.
- Anytime in life, having have used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.
- Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning
during the study (for example, subject's occupation requires regular sun exposure).
- Current smoker or history of smoking within 6 months of study participation.
- As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
