A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

Exclusion Criteria

• •history or clinical evidence of acute or chronic disease
• •history of malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area
• •history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
• •allergy to local anesthesia, including lidocaine and epinephrine
• •ongoing dermatologic disorders, except for folliculitis and acne
• •on therapy with steroids
• •on therapy with a drug that would affect collagen synthesis
• •positive urine test for nicotine or drugs of abuse
• •positive blood test for HIV 1 or 2, hepatitis B or hepatitis C
• •positive blood test for anti-AZX100 antibodies
• •participation in another study within 60 days prior to enrollment
• •donate blood within 7 days before dosing with study drug
• •donate plasma within 3 days before dosing with study drug
• •have a tattoo within 3 cm of the keloid scar that will be removed
• •apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug
• •use a tanning bed or tanning light within 3 months before enrollment
• •intend to use any scar improving product during the study (one year)
• •history of drug addiction or excessive use of alcohol
• •previous drug treatment of the keloid scar that will be removed within the last 3 years; any laser, irradiation, or surgery of the keloid scar that will be removed