Dermal Cryotherapy for Treatment of Pigmented Lesions

Exclusion Criteria

• •1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
• •2. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
• •3. Scars or tattoos in the location of the treatment sites
• •4. History of vitiligo, eczema, or psoriasis in the area of treatment
• •5. History of melanoma
• •6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
• •7. History of abnormal wound healing or abnormal scarring
• •8. Inability or unwillingness to comply with the study requirements.
• •9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
• •10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.