A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars
Condition: Scar Prevention; Scar Reduction
MeSH terms: Keloid
Intervention: AZX100 Drug Product; AZX100 Drug Product; Placebo
Intervention description: Subjects were administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.; Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.; Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AZX100; Patient and Observer Scar Assessment Scale; POSAS; Visual Analog Scale; VAS; Keloid; 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 re-growth of surgically removed keloid
      scars.
    

Eligibility criteria:

        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