Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin

Exclusion Criteria

• •. Subjects with a history of melanoma anywhere on the body.
• •Subjects with any unstable medical condition as determined by the clinical investigator.
• •Subjects with untreated non-melanoma skin cancer on the face or within the treatment area.
• •Subjects with dermatitis or any dermatologic disease in the treatment area that would obscure the evaluation of photoaging parameters.
• •Subjects who have undergone any form of 'field treatment' including 5-fluorouracil, photodynamic therapy, or ingenol mebutate in the preceeding six months.
• •Women who are pregnant, lactating, or planning to become pregnant during the study period.
• •Subjects who have experienced a major medical event (including stroke, heart attack, etc) within 90 days of starting the study.
• •Subjects who have active substance abuse disorders.
• •Subjects who have known allergies to any components of the study drug.
• •Subjects who are currently particpating in another clinical trial or who have completed a study involving laser, systemic, or topical treatment of the face within 30 days prior to study treatment initiation.
• •Subjects who have received any of the following within 90 days prior to study treatment initiation:
• •Interferon or interferon inducers
• •Cytotoxic drugs
• •Immunomodulators or immunosuppressive treatments (except inhaled or intranasal corticosteroids)
• •Oral or parenteral corticosteroids
• •Topical steroids to treatment area
• •Any dermatologic procedures or surgeries to the treatment area, including cryosurgery for AKs
• •Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation