Conditions: Scar Prevention Scar Reduction
Keywords: AZX100 Patient and Observer Scar Assessment Scale POSAS Visual Analog Scale VAS Keloid Scarring Scar reduction Scar prevention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: AZX100 Drug Product intervention 2: AZX100 Drug Product intervention 3: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document: