Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).

Inclusion Criteria:

• Fitzpatrick Skin Type I - III
• Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest
• Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area
• Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study
• Willing and able to read, understand and sign the Informed Consent Form
• Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions

Exclusion Criteria:

• Any laser treatment on neck and/or chest within 12 months
• Any topical treatment on neck and/or chest within 6 months
• Pregnant and/or breastfeeding
• Infection, dermatitis or a rash in the treatment area
• Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders
• History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
• Having a known anticoagulative condition or taking anticoagulation medications
• History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen
• Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
• History of radiation to the head, neck and/or upper chest
• Undergoing systemic chemotherapy for the treatment of cancer
• Systemic use of isotretinoin (Accutane®) within 6 months
• Any use of gold therapy
• Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
• Current smoker or history of smoking within 12 months of study
• Participation in a study of another device or drug within 6 months
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study