| Eligibility |
Inclusion Criteria:
Healthy male or female, 18 years or older Fitzpatrick skin type I-IV Has visible signs of
moderate to severe skin pigmentation Willing to have multiple biopsies taken from treatment
location at various time points Willing to not use any other procedure(s) in the treatment
area during the study, such as laser 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 for the duration of the study. (applicable to female subjects only) 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
Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes 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
Must be willing to adhere to the treatment and follow-up schedule and post-treatment care
instructions
Exclusion Criteria:
Fitzpatrick skin type V-VI 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. Pregnant and/or breastfeeding (applicable
to female subjects only) 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
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