Laser Removal of Age (Sun) Spots on Hands

This is an interventional treatment trial for Solar Lentigines focused on measuring Sun, Age, Spot Read More

Inclusion Criteria:

• Females or Males, 18 to 60 years of age (inclusive).
• Fitzpatrick Skin Type I - III (Appendix 2).
• Clinical diagnosis of benign solar lentigines of the hands.
• Presence of at least 5 lesions in the treatment area in diameters ranging from 1 to 8 mm.
• Has not used any prescription or over the counter topical creams (e.g., hydroquinone, and/or retinoids and/or corticosteroids) used in the treatment of pigmentation in the treatment area within the last 4 weeks.
• Willing to refrain from using any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, and/or retinoids and/or corticosteroids) in the treatment area during the study period.
• Must be able to read, understand and sign the Informed Consent Form.
• Willing and able to adhere to the treatment and follow-up schedule and before and after treatment care instructions.
• Willing to protect and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher in the treatment area starting up to 4 weeks before the treatment, every day for the duration of the study, including the follow-up period
• Willing to have digital photographs taken of the treatment area
• Agree not to undergo any other procedure(s) for the treatment of solar lentigines during the study.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at last 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

• Participation in a study of another device of drug within 6 months prior to enrollment or during the study.
• Prior treatment of solar lentigines of the hands, e.g., with Q-Switched laser, IPL, Chemical peel, cryotherapy within 6 months of study participation.
• Having pre-malignant or malignant lesions (e.g., pigmented actinic keratosis, lentigo maligna [12], lentigo maligna melanoma), or history of a pre-malignant or malignant lesion in the treatment area.
• Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study.
• Skin abnormalities in the treatment 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 immunosuppression medications.
• History of vitiligo 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, such as tetracycline.
• 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.
• Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• Current smoker or history of smoking within 2 years 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.
• History of allergy to topical antibiotics.