A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients

A Phase 2a Double Blind, Placebo Within-Patient Controlled, Multi-Center Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product in Trocar Sites of Arthroscopic Shoulder Surgery Patients

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 scars that were made from trocars following arthroscopic shoulder surgery.

Inclusion Criteria:

• Scheduled for an arthroscopic shoulder surgery that will result in at least 3 trocar sites
• Healthy male or non-pregnant female 18-75 years old
• Non-diabetic
• Body Mass Index 18-35
• No clinically significant abnormal values on blood test
• Non-smoker for previous 6 months

Exclusion Criteria:

• History of acute or chronic disease
• Cancer within previous 5 years, except for removed skin cancer
• Hypersensitivity reaction
• Allergy to general anesthesia, lidocaine, or epinephrine
• Current skin disorder other than folliculitis or acne
• On therapy with steroids
• On therapy with a drug that affects collagen synthesis
• Positive for HIV or hepatitis
• Positive urine test for nicotine
• Positive blood test for anti-AZX100 antibodies
• Participated in another clinical study within 60 days before enrollment
• Gave blood within 7 days before dosing
• Gave plasma within 3 days before dosing
• Tattoo on the shoulder area
• Applied any prescribed or over the counter agents to the shoulder within 14 days before dosing, or intend to use any scar improving product
• Visited a tanning salon within 14 days before dosing
• History of drug addiction or excessive use of alcohol