A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit

Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).

Time frame: 52 weeks after initial scar revision surgery in study B5301001

Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities

Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.

Time frame: Part B: Baseline up to Week 15

Part B: Number of Participants With Clinical Laboratory Abnormalities

Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.

Time frame: Part B: Baseline up to Week 15

Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.