A PHASE 2, OPEN-LABEL STUDY TO PROVIDE REVISION OF SCARS RESULTING FROM SURGERY IN PRIOR STUDIES OF EXC 001

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: Week 2 to Week 24

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. AEs included SAEs and all non-SAEs that occurred during the study.

Number of Participants With Clinically Significant Findings in Laboratory Examinations

时间窗: Day 1 up to Week 24

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )\[pH\], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion.

Number of Participants With Positive Skin Sensitivity Reaction

时间窗: Day 1 up to Week 24

Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appeared to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. In this outcome measure number of participants with any positive skin sensitivity reaction were reported.

Number of Participants With Clinically Significant Change in Vital Signs

时间窗: Day 1 up to Week 24

Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion.

Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities

时间窗: Day 1 up to Week 24

Following parameters were analyzed: heart rate, PR interval, QT interval, QRS interval and QT interval corrected using Fridericia's formula (QTcF). Clinically significant findings in ECG were based on investigator's discretion.

Number of Participants With Abnormalities in Physical Examinations

时间窗: Day 1 up to Week 24

Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion.