A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients
Condition: Scar Prevention; Scar Reduction
MeSH terms: Cicatrix
Intervention: Placebo; AZX100
Intervention description: Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.; AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: AZX100; Patient and Observer Scar Assessment Scale; POSAS; Visual Analog Scale; VAS; Trocar; Scarring; Scar reduction; Scar prevention

Summary:

      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.
    

Eligibility criteria:

        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