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

A Pilot Phase 2a Blinded, Placebo Controlled, Multicenter Parallel Group, Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product Following Excision of Keloids

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

Inclusion Criteria:

• keloid scar between 1 and 3 cm long, less than 1 cm at its widest point
• willing to undergo keloid scar removal surgery
• healthy adult male or non-pregnant female
• non-diabetic
• Body Mass Index in the range of 18-35
• no clinically significant abnormal values on a full blood safety screen
• non-smoker and non-nicotine user for the previous six months

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