Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Expert Panel Scar Assessment Score at Week 12 |
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. |
Part B: Week 12 |
|
Secondary |
Expert Panel Scar Assessment Score at Week 8 and 24 |
Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. |
Part B: Week 8 and 24 |
|
Secondary |
Physician Observer Scar Assessment Score at Week 12 and 24 |
Physician observer assessment of scar was done using a valid published 10-point rating scale. Physician rated 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, where higher scores indicate worse condition. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where higher scores indicate worse condition. |
Part B: Week 12 and 24 |
|
Secondary |
Participant Observer Scar Assessment Score at Week 12 and 24 |
Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range =1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range =1 (no, same as normal skin) to 10 (yes, very different), where higher scores indicate worse condition. Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst), where higher scores indicate worse condition. Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst), where higher scores indicate worse condition. |
Part B: Week 12 and 24 |
|
Secondary |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
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. |
Part A: Day 1; Part B, Active Dosing: Week 2 up to Week 13; Part B, Post Dosing: Week 13 to end of the study (Week 24) |
|
Secondary |
Number of Participants With Abnormal Physical Examination Findings |
Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Abnormal physical examination findings was based on investigator's discretion. |
Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12 |
|
Secondary |
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) |
Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion. |
Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12 |
|
Secondary |
Number of Participants With Clinically Significant Findings in Laboratory Examinations |
Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant findings were reported. |
Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 |
|
Secondary |
Number of Participants With Clinically Significant Findings in Vital Signs |
Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Clinical significance was based on investigator's discretion. |
Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 |
|
Secondary |
Number of Participants With Positive Skin Sensitivity Reaction |
Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appears to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. |
Part A: Day 1, Part B: Week 2 up to Week 24 |
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