Scar Prevention
Conditions
Keywords
Scarring, Cicatrix, Fibrosis, Pathologic Process
Brief summary
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
Interventions
DRUGEXC 001
Multiple intradermal injections of EXC 001 and placebo
DRUGPlacebo
Multiple intradermal injections of EXC 001 and placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have previously had breast surgery resulting in unacceptable scars * Subject has chosen to have the breast scars revised * Subjects must not be pregnant or lactating
Exclusion criteria
* Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or lactating * Participation in another clinical trial within 30 days prior to the start of the study * Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expert Panel Scar Assessment Score at Week 12 | Part B: 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Observer Scar Assessment Score at Week 12 and 24 | Part B: 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. |
| Participant Observer Scar Assessment Score at Week 12 and 24 | Part B: 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. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | 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 Abnormal Physical Examination Findings | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12 | 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. |
| Expert Panel Scar Assessment Score at Week 8 and 24 | Part B: 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. |
| Number of Participants With Clinically Significant Findings in Laboratory Examinations | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 | 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. |
| Number of Participants With Clinically Significant Findings in Vital Signs | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 | 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. |
| Number of Participants With Positive Skin Sensitivity Reaction | Part A: Day 1, Part B: Week 2 up to Week 24 | 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. |
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12 | Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion. |
Countries
United States
Participant flow
Recruitment details
Participants who elected to revise appearance of bilateral scars from previous breast surgery, were recruited in this study. Study had 2 parts- Part A and B. Participants with negative skin sensitization in Part A (skin testing) were assigned to Part B (scar revision surgery) of the study.
Pre-assignment details
Safety assessment was not planned separately for EXC 001 (PF-0647387) and placebo. All participants acted as their own control receiving both EXC 001 and placebo on the same days during Part B of the study.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants All participants who were enrolled in the study. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part A: Skin Testing | Adverse Event | 1 | 0 |
| Part A: Skin Testing | Protocol Violation | 1 | 0 |
| Part B: Scar Revision | Assigned But Not Treated | 0 | 1 |
| Part B: Scar Revision | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 8.77 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 25 | 16 / 22 | 3 / 22 |
| serious Total, serious adverse events | 0 / 25 | 1 / 22 | 0 / 22 |
Outcome results
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.
Time frame: Part B: Week 12
Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EXC 001 During Part B | Expert Panel Scar Assessment Score at Week 12 | 36.6 millimeter | Standard Deviation 12.68 |
| Placebo During Part B | Expert Panel Scar Assessment Score at Week 12 | 51.4 millimeter | Standard Deviation 14.54 |
Comparison: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-21.3, -8.1]t-test, 2 sided
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.
Time frame: Part B: Week 8 and 24
Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score. Here 'Number Analyzed' signifies those participants who were evaluable at specified time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 During Part B | Expert Panel Scar Assessment Score at Week 8 and 24 | Week 8 | 34.7 millimeter | Standard Deviation 11.18 |
| EXC 001 During Part B | Expert Panel Scar Assessment Score at Week 8 and 24 | Week 24 | 30.7 millimeter | Standard Deviation 13.55 |
| Placebo During Part B | Expert Panel Scar Assessment Score at Week 8 and 24 | Week 8 | 49.4 millimeter | Standard Deviation 13.96 |
| Placebo During Part B | Expert Panel Scar Assessment Score at Week 8 and 24 | Week 24 | 56.7 millimeter | Standard Deviation 22.56 |
Comparison: Week 8: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-21.2, -8.3]t-test, 2 sided
Comparison: Week 24: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-34.3, -17.7]t-test, 2 sided
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.
Time frame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12
Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 During Part B | Number of Participants With Abnormal Physical Examination Findings | Screening | 14 Participants |
| EXC 001 During Part B | Number of Participants With Abnormal Physical Examination Findings | Day 1 of Part B | 3 Participants |
| EXC 001 During Part B | Number of Participants With Abnormal Physical Examination Findings | Week 12 of Part B | 1 Participants |
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.
Time frame: 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)
Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 During Part B | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 9 Participants |
| EXC 001 During Part B | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo During Part B | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 16 Participants |
| Placebo During Part B | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Part B, Post Dosing Phase | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part B, Post Dosing Phase | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
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.
Time frame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12
Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 During Part B | Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Part B: Week 12 | 0 Participants |
| EXC 001 During Part B | Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Screening | 0 Participants |
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.
Time frame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 During Part B | Number of Participants With Clinically Significant Findings in Laboratory Examinations | Screening | 0 Participants |
| EXC 001 During Part B | Number of Participants With Clinically Significant Findings in Laboratory Examinations | Part B: Day 1 up to Week 12 | 2 Participants |
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.
Time frame: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 During Part B | Number of Participants With Clinically Significant Findings in Vital Signs | Screening | 0 Participants |
| EXC 001 During Part B | Number of Participants With Clinically Significant Findings in Vital Signs | Part B: Day 1 up to Week 12 | 1 Participants |
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.
Time frame: Part A: Day 1, Part B: Week 2 up to Week 24
Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EXC 001 During Part B | Number of Participants With Positive Skin Sensitivity Reaction | 0 Participants |
| Placebo During Part B | Number of Participants With Positive Skin Sensitivity Reaction | 0 Participants |
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.
Time frame: Part B: Week 12 and 24
Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Thickness | 4.4 units on a scale | Standard Deviation 2.94 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Pain | 1.5 units on a scale | Standard Deviation 1.08 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Pain | 2.0 units on a scale | Standard Deviation 2.13 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Itching | 1.9 units on a scale | Standard Deviation 2 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Irregular | 4.6 units on a scale | Standard Deviation 3.23 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Color | 5.2 units on a scale | Standard Deviation 3.14 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Color | 6.3 units on a scale | Standard Deviation 3.07 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Stiffness | 3.6 units on a scale | Standard Deviation 2.62 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Overall Opinion | 3.7 units on a scale | Standard Deviation 1.9 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Thickness | 3.6 units on a scale | Standard Deviation 2.48 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Scar Appearance Composite Score | 16.7 units on a scale | Standard Deviation 9.37 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Irregular | 4.3 units on a scale | Standard Deviation 2.49 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Composite Score | 24.0 units on a scale | Standard Deviation 13.46 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Overall Opinion | 4.1 units on a scale | Standard Deviation 2.48 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Itching | 2.6 units on a scale | Standard Deviation 2.82 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Composite Score | 20.1 units on a scale | Standard Deviation 9.96 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Scar Appearance Composite Score | 19.3 units on a scale | Standard Deviation 10.95 |
| EXC 001 During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Stiffness | 4.0 units on a scale | Standard Deviation 2.81 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Scar Appearance Composite Score | 24.9 units on a scale | Standard Deviation 11.61 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Pain | 2.7 units on a scale | Standard Deviation 1.93 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Itching | 3.0 units on a scale | Standard Deviation 2.87 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Color | 6.8 units on a scale | Standard Deviation 2.91 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Stiffness | 5.1 units on a scale | Standard Deviation 3.42 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Thickness | 5.5 units on a scale | Standard Deviation 2.96 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Irregular | 5.8 units on a scale | Standard Deviation 3.11 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Overall Opinion | 4.8 units on a scale | Standard Deviation 2.62 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Composite Score | 28.9 units on a scale | Standard Deviation 13.79 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 12: Scar Appearance Composite Score | 23.3 units on a scale | Standard Deviation 10.97 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Pain | 2.4 units on a scale | Standard Deviation 2.36 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Itching | 2.5 units on a scale | Standard Deviation 2.32 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Color | 7.0 units on a scale | Standard Deviation 2.77 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Stiffness | 5.8 units on a scale | Standard Deviation 3.33 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Thickness | 6.0 units on a scale | Standard Deviation 3.26 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Irregular | 6.1 units on a scale | Standard Deviation 3.2 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Overall Opinion | 6.5 units on a scale | Standard Deviation 2.93 |
| Placebo During Part B | Participant Observer Scar Assessment Score at Week 12 and 24 | Week 24: Composite Score | 29.9 units on a scale | Standard Deviation 13.8 |
Comparison: Week 12 Pain: Comparison within the participant between EXC 001 and placebo.p-value: 0.06795% CI: [-1.3, 0]t-test, 2 sided
Comparison: Week 12, Itching: Comparison within the participant between EXC 001 and placebo.p-value: 0.41395% CI: [-1.2, 0.5]t-test, 2 sided
Comparison: Week 12, Color: Comparison within the participant between EXC 001 and placebo.p-value: 0.40195% CI: [-1.6, 0.7]t-test, 2 sided
Comparison: Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.p-value: 0.08395% CI: [-2.4, 0.2]t-test, 2 sided
Comparison: Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.p-value: 0.05295% CI: [-2.3, 0]t-test, 2 sided
Comparison: Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.p-value: 0.03695% CI: [-2.3, -0.1]t-test, 2 sided
Comparison: Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.p-value: 0.04595% CI: [-2.1, 0]t-test, 2 sided
Comparison: Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.p-value: 0.05495% CI: [-9.9, 0.1]t-test, 2 sided
Comparison: Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.p-value: 0.06595% CI: [-8.2, 0.3]t-test, 2 sided
Comparison: Week 24, Pain: Comparison within the participant between EXC 001 and placebo.p-value: 0.07995% CI: [-2, 0.1]t-test, 2 sided
Comparison: Week 24, Itching: Comparison within the participant between EXC 001 and placebo.p-value: 0.15895% CI: [-1.5, 0.3]t-test, 2 sided
Comparison: Week 24, Color: Comparison within the participant between EXC 001 and placebo.p-value: 0.0195% CI: [-3, -0.5]t-test, 2 sided
Comparison: Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.p-value: 0.00395% CI: [-3.5, -0.8]t-test, 2 sided
Comparison: Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.p-value: 0.00595% CI: [-4, -0.8]t-test, 2 sided
Comparison: Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.p-value: 0.03295% CI: [-3.5, -0.2]t-test, 2 sided
Comparison: Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.p-value: 0.00395% CI: [-3.8, -0.9]t-test, 2 sided
Comparison: Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.p-value: 0.00695% CI: [-16.4, -3.1]t-test, 2 sided
Comparison: Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.p-value: 0.00495% CI: [-13.4, -3]t-test, 2 sided
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.
Time frame: Part B: Week 12 and 24
Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Vascularity | 4.0 units on a scale | Standard Deviation 1.75 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Vascularity | 3.5 units on a scale | Standard Deviation 1.29 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Pliability | 3.6 units on a scale | Standard Deviation 1.66 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Pigmentation | 3.5 units on a scale | Standard Deviation 1.21 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Thickness | 3.8 units on a scale | Standard Deviation 1.58 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Thickness | 4.0 units on a scale | Standard Deviation 1.82 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Relief | 3.2 units on a scale | Standard Deviation 1.78 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Surface Area | 3.9 units on a scale | Standard Deviation 1.53 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Pliability | 3.2 units on a scale | Standard Deviation 1.73 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Pigmentation | 3.4 units on a scale | Standard Deviation 1.33 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Surface Area | 3.7 units on a scale | Standard Deviation 1.71 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Overall Opinion | 3.7 units on a scale | Standard Deviation 1.46 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Overall Opinion | 3.6 units on a scale | Standard Deviation 1.43 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Relief | 3.4 units on a scale | Standard Deviation 1.69 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Composite Score | 21.0 units on a scale | Standard Deviation 7.79 |
| EXC 001 During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Composite Score | 22.1 units on a scale | Standard Deviation 7.53 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Composite Score | 33.6 units on a scale | Standard Deviation 10.11 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Vascularity | 5.2 units on a scale | Standard Deviation 1.67 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Pigmentation | 4.6 units on a scale | Standard Deviation 1.8 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Thickness | 5.4 units on a scale | Standard Deviation 2.18 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Relief | 5.2 units on a scale | Standard Deviation 2.47 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Pliability | 4.7 units on a scale | Standard Deviation 2.15 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Surface Area | 5.3 units on a scale | Standard Deviation 1.77 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Overall Opinion | 5.5 units on a scale | Standard Deviation 1.83 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 12: Composite Score | 30.5 units on a scale | Standard Deviation 10.42 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Vascularity | 5.8 units on a scale | Standard Deviation 1.95 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Pigmentation | 5.4 units on a scale | Standard Deviation 1.86 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Relief | 5.6 units on a scale | Standard Deviation 2.29 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Pliability | 5.2 units on a scale | Standard Deviation 2.34 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Surface Area | 5.9 units on a scale | Standard Deviation 1.8 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Overall Opinion | 6.0 units on a scale | Standard Deviation 1.7 |
| Placebo During Part B | Physician Observer Scar Assessment Score at Week 12 and 24 | Week 24: Thickness | 5.8 units on a scale | Standard Deviation 1.83 |
Comparison: Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.p-value: 0.03395% CI: [-2.3, -0.1]t-test, 2 sided
Comparison: Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.p-value: 0.00395% CI: [-1.9, -0.4]t-test, 2 sided
Comparison: Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-2.5, -0.8]t-test, 2 sided
Comparison: Week 12, Relief: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-2.7, -1]t-test, 2 sided
Comparison: Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.p-value: 0.01295% CI: [-1.9, -0.3]t-test, 2 sided
Comparison: Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.p-value: 0.00395% CI: [-2.4, -0.5]t-test, 2 sided
Comparison: Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-2.6, -1.1]t-test, 2 sided
Comparison: Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-12.7, -4]t-test, 2 sided
Comparison: Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-3.2, -1.4]t-test, 2 sided
Comparison: Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-2.9, -0.9]t-test, 2 sided
Comparison: Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.p-value: 0.00195% CI: [-2.8, -0.8]t-test, 2 sided
Comparison: Week 24, Relief: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-3.6, -1.3]t-test, 2 sided
Comparison: Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.p-value: 0.00595% CI: [-3.2, -0.7]t-test, 2 sided
Comparison: Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-3.1, -1.2]t-test, 2 sided
Comparison: Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-3.3, -1.5]t-test, 2 sided
Comparison: Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.p-value: <0.00195% CI: [-17.7, -7.4]t-test, 2 sided