Reduction of Hypertrophic Skin Scarring
Conditions
Keywords
Skin scarring, cicatrix, breast scar, hypertrophic scar
Brief summary
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.
Interventions
DRUGPF-06473871
Single dose administered by injection four different times
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have hypertrophic (raised) breast scars from previous surgery * Subjects must be healthy
Exclusion criteria
* Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding. * Presence of history of breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | Week 24 | Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Week 8, 11, 18, 24 | 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). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1. |
| Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 8, 11, 18, 24 | Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received |
| Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Week 8, 24 | PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing \[14 attributes\]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received. |
| Physician and Participant Photoguide Scar Assessment Scale Score | Week 8, 11, 18, 24 | Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to Week 24 | Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight. |
| Number of Participants With Abnormal Physical Examinations | Baseline up to Week 24 | Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems. |
| Number of Participants With Electrocardiogram Findings | Baseline, Week 11 | Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest | Baseline up to Week 24 | Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Baseline up to Week 24 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported. |
Countries
Germany, Hungary, Spain, United States
Participant flow
Pre-assignment details
A total of 103 participants were randomized into the study. Of these, 100 participants received at least 1 dose of study drug and were included in the modified intent to treat (mITT) and safety population.
Participants by arm
| Arm | Count |
|---|---|
| PF-06473871/Placebo (4* 5 mg/cm) Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast. | 45 |
| PF-06473871/Placebo (3* 5 mg/cm) Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast. | 55 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Un-specified | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | PF-06473871/Placebo (3* 5 mg/cm) | PF-06473871/Placebo (4* 5 mg/cm) | Total |
|---|---|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 9.64 | 38.2 years STANDARD_DEVIATION 8.55 | 37.9 years STANDARD_DEVIATION 9.13 |
| Pre-Surgery Participant Photoguide Score | 4.28 units on scale STANDARD_DEVIATION 0.637 | 4.24 units on scale STANDARD_DEVIATION 0.648 | 4.26 units on scale STANDARD_DEVIATION 0.639 |
| Pre-Surgery Physician Overall Opinion POSAS Score | 6.88 units on scale STANDARD_DEVIATION 1.277 | 6.62 units on scale STANDARD_DEVIATION 1.545 | 6.76 units on scale STANDARD_DEVIATION 1.404 |
| Pre-Surgery Physician Photoguide Score | 3.98 units on scale STANDARD_DEVIATION 0.725 | 3.97 units on scale STANDARD_DEVIATION 0.682 | 3.98 units on scale STANDARD_DEVIATION 0.702 |
| Pre-Surgery Subject Global Assessment Score | 8.49 units on scale STANDARD_DEVIATION 1.617 | 9.00 units on scale STANDARD_DEVIATION 1.219 | 8.72 units on scale STANDARD_DEVIATION 1.465 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 27 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Female | 53 Participants | 44 Participants | 97 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 45 | 35 / 55 |
| serious Total, serious adverse events | 0 / 45 | 0 / 55 |
Outcome results
Primary
Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.
Time frame: Week 24
Population: Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | 4.00 units on scale | Standard Error 0.3 |
| Group 1: Placebo 4* 5 mg/cm | Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | 4.68 units on scale | Standard Error 0.27 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | 4.61 units on scale | Standard Error 0.29 |
| Group 2: Placebo 3* 5 mg/cm | Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | 4.86 units on scale | Standard Error 0.28 |
Comparison: A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.021990% CI: [0.19, 1.16]Repeated measures model
Comparison: A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.403890% CI: [-0.24, 0.72]Repeated measures model
Secondary
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received
Time frame: Week 8, 11, 18, 24
Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 24: (n=43,43,53,53) | 5.65 units on scale | Standard Error 0.39 |
| Group 1: PF-06473871: 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 8: (n=43,43,51,51) | 5.38 units on scale | Standard Error 0.33 |
| Group 1: PF-06473871: 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 18: (n=40,40,52,52) | 5.34 units on scale | Standard Error 0.38 |
| Group 1: PF-06473871: 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 11: (n=43,43,52,52) | 5.58 units on scale | Standard Error 0.33 |
| Group 1: Placebo 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 18: (n=40,40,52,52) | 5.78 units on scale | Standard Error 0.36 |
| Group 1: Placebo 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 24: (n=43,43,53,53) | 5.94 units on scale | Standard Error 0.37 |
| Group 1: Placebo 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 8: (n=43,43,51,51) | 5.48 units on scale | Standard Error 0.31 |
| Group 1: Placebo 4* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 11: (n=43,43,52,52) | 5.59 units on scale | Standard Error 0.32 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 18: (n=40,40,52,52) | 5.18 units on scale | Standard Error 0.36 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 11: (n=43,43,52,52) | 4.52 units on scale | Standard Error 0.32 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 24: (n=43,43,53,53) | 5.33 units on scale | Standard Error 0.38 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 8: (n=43,43,51,51) | 5.09 units on scale | Standard Error 0.32 |
| Group 2: Placebo 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 24: (n=43,43,53,53) | 5.15 units on scale | Standard Error 0.35 |
| Group 2: Placebo 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 18: (n=40,40,52,52) | 5.18 units on scale | Standard Error 0.33 |
| Group 2: Placebo 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 11: (n=43,43,52,52) | 4.73 units on scale | Standard Error 0.3 |
| Group 2: Placebo 3* 5 mg/cm | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Week 8: (n=43,43,51,51) | 5.20 units on scale | Standard Error 0.29 |
Comparison: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.755290% CI: [-0.44, 0.64]Repeated measures model
Comparison: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.660590% CI: [-0.3, 0.52]Repeated measures model
Comparison: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.984290% CI: [-0.55, 0.56]Repeated measures model
Comparison: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.40190% CI: [-0.21, 0.63]Repeated measures model
Comparison: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.249190% CI: [-0.19, 1.07]Repeated measures model
Comparison: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.99890% CI: [-0.47, 0.47]Repeated measures model
Comparison: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.47390% CI: [-0.37, 0.93]Repeated measures model
Comparison: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871p-value: 0.541390% CI: [-0.67, 0.31]Repeated measures model
Secondary
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing \[14 attributes\]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.
Time frame: Week 8, 24
Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 8: (n=43,43,53,53) | 17.89 units on scale | Standard Error 2.62 |
| Group 1: PF-06473871: 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 8: (n=43,43,53,53) | 34.95 units on scale | Standard Error 2.38 |
| Group 1: PF-06473871: 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 24: (n=43,43,54,54) | 13.74 units on scale | Standard Error 2.75 |
| Group 1: PF-06473871: 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 24: (n=43,43,54,54) | 43.55 units on scale | Standard Error 3.32 |
| Group 1: Placebo 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 8: (n=43,43,53,53) | 17.19 units on scale | Standard Error 2.34 |
| Group 1: Placebo 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 24: (n=43,43,54,54) | 15.49 units on scale | Standard Error 2.45 |
| Group 1: Placebo 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 24: (n=43,43,54,54) | 47.37 units on scale | Standard Error 3.16 |
| Group 1: Placebo 4* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 8: (n=43,43,53,53) | 36.27 units on scale | Standard Error 2.27 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 24: (n=43,43,54,54) | 18.22 units on scale | Standard Error 2.81 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 8: (n=43,43,53,53) | 18.46 units on scale | Standard Error 2.71 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 24: (n=43,43,54,54) | 42.41 units on scale | Standard Error 3.04 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 8: (n=43,43,53,53) | 34.50 units on scale | Standard Error 2.2 |
| Group 2: Placebo 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 24: (n=43,43,54,54) | 17.09 units on scale | Standard Error 2.57 |
| Group 2: Placebo 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Symptoms: Week 8: (n=43,43,53,53) | 16.92 units on scale | Standard Error 2.47 |
| Group 2: Placebo 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 8: (n=43,43,53,53) | 34.14 units on scale | Standard Error 2.2 |
| Group 2: Placebo 3* 5 mg/cm | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | Appearance: Week 24: (n=43,43,54,54) | 42.56 units on scale | Standard Error 3.04 |
Comparison: Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-3.28, 5.92]
Comparison: Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-3.63, 2.91]
Comparison: Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-2.6, 10.24]
Comparison: Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-4.37, 4.68]
Comparison: Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-4.34, 2.95]
Comparison: Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-4.53, 1.45]
Comparison: Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-2.07, 5.58]
Comparison: Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-4.24, 1.99]
Secondary
Physician and Participant Photoguide Scar Assessment Scale Score
Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.
Time frame: Week 8, 11, 18, 24
Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 8 (n=43,43,52,52) | 2.35 units on scale | Standard Error 0.15 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 11 (n=43,43,53,53) | 2.42 units on scale | Standard Error 0.15 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 18 (n=40,40,53,53) | 2.48 units on scale | Standard Error 0.15 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 24 (n=43,43,54,54) | 2.60 units on scale | Standard Error 0.15 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 8 (n=43,43,52,52) | 2.41 units on scale | Standard Error 0.16 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 11 (n=43,43,53,53) | 2.65 units on scale | Standard Error 0.16 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 18 (n=39,39,53,53) | 2.38 units on scale | Standard Error 0.16 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 24 (n=43,43,54,54) | 2.75 units on scale | Standard Error 0.16 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 11 (n=43,43,53,53) | 2.66 units on scale | Standard Error 0.16 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 8 (n=43,43,52,52) | 2.51 units on scale | Standard Error 0.16 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 11 (n=43,43,53,53) | 2.71 units on scale | Standard Error 0.14 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 24 (n=43,43,54,54) | 2.95 units on scale | Standard Error 0.16 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 18 (n=39,39,53,53) | 2.80 units on scale | Standard Error 0.17 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 24 (n=43,43,54,54) | 3.03 units on scale | Standard Error 0.14 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 18 (n=40,40,53,53) | 3.05 units on scale | Standard Error 0.14 |
| Group 1: Placebo 4* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 8 (n=43,43,52,52) | 2.45 units on scale | Standard Error 0.14 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 18 (n=39,39,53,53) | 2.80 units on scale | Standard Error 0.15 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 18 (n=40,40,53,53) | 2.70 units on scale | Standard Error 0.16 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 24 (n=43,43,54,54) | 3.00 units on scale | Standard Error 0.16 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 8 (n=43,43,52,52) | 2.28 units on scale | Standard Error 0.15 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 11 (n=43,43,53,53) | 2.48 units on scale | Standard Error 0.15 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 24 (n=43,43,54,54) | 2.75 units on scale | Standard Error 0.15 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 8 (n=43,43,52,52) | 2.24 units on scale | Standard Error 0.16 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 11 (n=43,43,53,53) | 2.58 units on scale | Standard Error 0.16 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 18 (n=40,40,53,53) | 2.74 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 24 (n=43,43,54,54) | 3.07 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 11 (n=43,43,53,53) | 2.48 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Physician: Week 8 (n=43,43,52,52) | 2.28 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 8 (n=43,43,52,52) | 2.25 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 24 (n=43,43,54,54) | 2.89 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 18 (n=39,39,53,53) | 2.79 units on scale | Standard Error 0.14 |
| Group 2: Placebo 3* 5 mg/cm | Physician and Participant Photoguide Scar Assessment Scale Score | Participant: Week 11 (n=43,43,53,53) | 2.56 units on scale | Standard Error 0.14 |
Comparison: Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.04, 0.54]
Comparison: Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.36, 0.15]
Comparison: Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.15, 0.35]
Comparison: Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.22, 0.29]
Comparison: Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.32, 0.82]
Comparison: Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.21, 0.3]
Comparison: Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.18, 0.68]
Comparison: Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.18, 0.32]
Comparison: Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.2, 0.39]
Comparison: Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.28, 0.23]
Comparison: Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.29, 0.3]
Comparison: Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.18, 0.33]
Comparison: Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.12, 0.72]
Comparison: Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.27, 0.24]
Comparison: Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.09, 0.5]
Comparison: Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.11, 0.4]
Secondary
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
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). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.
Time frame: Week 8, 11, 18, 24
Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 11 (n=43,43,52,52) | 3.55 units on scale | Standard Error 0.27 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 8 (n=43,43,51,51) | 3.50 units on scale | Standard Error 0.22 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 24 (n=43,43,53,53) | 3.73 units on scale | Standard Error 0.34 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 8 (n=43,43,51,51) | 3.19 units on scale | Standard Error 0.23 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 11(n=43,43,52,52) | 3.63 units on scale | Standard Error 0.26 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 18 (n=40,40,52,52) | 3.75 units on scale | Standard Error 0.31 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 18 (n=40,40,52,52) | 3.46 units on scale | Standard Error 0.31 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 24 (n=43,43,53,53) | 3.87 units on scale | Standard Error 0.3 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 18 (n=40,40,52,52) | 3.86 units on scale | Standard Error 0.29 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 11(n=43,43,52,52) | 3.71 units on scale | Standard Error 0.28 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 8 (n=43,43,51,51) | 3.55 units on scale | Standard Error 0.25 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 8 (n=43,43,51,51) | 3.63 units on scale | Standard Error 0.24 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 24 (n=43,43,53,53) | 3.90 units on scale | Standard Error 0.32 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 24 (n=43,43,53,53) | 4.05 units on scale | Standard Error 0.33 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 18 (n=40,40,52,52) | 3.31 units on scale | Standard Error 0.27 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 24 (n=43,43,53,53) | 3.08 units on scale | Standard Error 0.27 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 11 (n=43,43,52,52) | 3.82 units on scale | Standard Error 0.25 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 18 (n=40,40,52,52) | 3.97 units on scale | Standard Error 0.31 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 8 (n=43,43,51,51) | 3.42 units on scale | Standard Error 0.23 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 11 (n=43,43,52,52) | 3.84 units on scale | Standard Error 0.27 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 18 (n=40,40,52,52) | 3.67 units on scale | Standard Error 0.32 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 11 (n=43,43,52,52) | 3.64 units on scale | Standard Error 0.25 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 18 (n=40,40,52,52) | 3.85 units on scale | Standard Error 0.29 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 24 (n=43,43,53,53) | 3.84 units on scale | Standard Error 0.29 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 8 (n=43,43,51,51) | 3.42 units on scale | Standard Error 0.25 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 8 (n=43,43,51,51) | 3.38 units on scale | Standard Error 0.23 |
| Group 1: PF-06473871: 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 11(n=43,43,52,52) | 3.58 units on scale | Standard Error 0.26 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 18 (n=40,40,52,52) | 3.73 units on scale | Standard Error 0.28 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 24 (n=43,43,53,53) | 4.27 units on scale | Standard Error 0.32 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 11(n=43,43,52,52) | 3.98 units on scale | Standard Error 0.26 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 24 (n=43,43,53,53) | 4.58 units on scale | Standard Error 0.33 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 18 (n=40,40,52,52) | 4.61 units on scale | Standard Error 0.29 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 8 (n=43,43,51,51) | 3.56 units on scale | Standard Error 0.24 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 8 (n=43,43,51,51) | 3.58 units on scale | Standard Error 0.24 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 24 (n=43,43,53,53) | 3.40 units on scale | Standard Error 0.28 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 18 (n=40,40,52,52) | 4.19 units on scale | Standard Error 0.3 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 18 (n=40,40,52,52) | 3.88 units on scale | Standard Error 0.29 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 18 (n=40,40,52,52) | 4.61 units on scale | Standard Error 0.32 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 18 (n=40,40,52,52) | 4.48 units on scale | Standard Error 0.32 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 8 (n=43,43,51,51) | 3.59 units on scale | Standard Error 0.23 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 24 (n=43,43,53,53) | 4.39 units on scale | Standard Error 0.31 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 8 (n=43,43,51,51) | 3.53 units on scale | Standard Error 0.23 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 11(n=43,43,52,52) | 3.85 units on scale | Standard Error 0.27 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 11 (n=43,43,52,52) | 4.06 units on scale | Standard Error 0.25 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 8 (n=43,43,51,51) | 3.84 units on scale | Standard Error 0.24 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 11 (n=43,43,52,52) | 4.05 units on scale | Standard Error 0.24 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 11(n=43,43,52,52) | 4.02 units on scale | Standard Error 0.27 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 8 (n=43,43,51,51) | 3.51 units on scale | Standard Error 0.25 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 11 (n=43,43,52,52) | 3.73 units on scale | Standard Error 0.27 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 24 (n=43,43,53,53) | 4.73 units on scale | Standard Error 0.3 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 11 (n=43,43,52,52) | 3.83 units on scale | Standard Error 0.26 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 18 (n=40,40,52,52) | 4.68 units on scale | Standard Error 0.27 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 24 (n=43,43,53,53) | 3.99 units on scale | Standard Error 0.29 |
| Group 1: Placebo 4* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 8 (n=43,43,51,51) | 3.74 units on scale | Standard Error 0.2 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 11(n=43,43,52,52) | 4.01 units on scale | Standard Error 0.25 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 24 (n=43,43,53,53) | 4.63 units on scale | Standard Error 0.31 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 8 (n=43,43,51,51) | 3.48 units on scale | Standard Error 0.24 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 11(n=43,43,52,52) | 3.89 units on scale | Standard Error 0.27 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 11 (n=43,43,52,52) | 4.13 units on scale | Standard Error 0.25 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 18 (n=40,40,52,52) | 4.35 units on scale | Standard Error 0.28 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 8 (n=43,43,51,51) | 3.95 units on scale | Standard Error 0.24 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 11 (n=43,43,52,52) | 3.76 units on scale | Standard Error 0.26 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 18 (n=40,40,52,52) | 3.49 units on scale | Standard Error 0.27 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 24 (n=43,43,53,53) | 3.34 units on scale | Standard Error 0.27 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 8 (n=43,43,51,51) | 3.49 units on scale | Standard Error 0.2 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 11 (n=43,43,52,52) | 3.80 units on scale | Standard Error 0.23 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 18 (n=40,40,52,52) | 3.73 units on scale | Standard Error 0.24 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 24 (n=43,43,53,53) | 4.16 units on scale | Standard Error 0.25 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 8 (n=43,43,51,51) | 3.59 units on scale | Standard Error 0.22 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 18 (n=40,40,52,52) | 4.18 units on scale | Standard Error 0.3 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 18 (n=40,40,52,52) | 3.99 units on scale | Standard Error 0.31 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 24 (n=43,43,53,53) | 4.38 units on scale | Standard Error 0.29 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 8 (n=43,43,51,51) | 3.57 units on scale | Standard Error 0.22 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 11(n=43,43,52,52) | 4.01 units on scale | Standard Error 0.25 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 18 (n=40,40,52,52) | 3.86 units on scale | Standard Error 0.27 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 24 (n=43,43,53,53) | 4.05 units on scale | Standard Error 0.3 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 8 (n=43,43,51,51) | 3.48 units on scale | Standard Error 0.22 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 11 (n=43,43,52,52) | 3.91 units on scale | Standard Error 0.23 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 18 (n=40,40,52,52) | 4.33 units on scale | Standard Error 0.26 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 24 (n=43,43,53,53) | 4.55 units on scale | Standard Error 0.28 |
| Group 2: PF¬06473871: 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 8 (n=43,43,51,51) | 3.66 units on scale | Standard Error 0.22 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 8 (n=43,43,51,51) | 3.75 units on scale | Standard Error 0.21 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 24 (n=43,43,53,53) | 4.54 units on scale | Standard Error 0.29 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 24 (n=43,43,53,53) | 4.12 units on scale | Standard Error 0.24 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 18 (n=40,40,52,52) | 3.75 units on scale | Standard Error 0.23 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 8 (n=43,43,51,51) | 3.37 units on scale | Standard Error 0.22 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 8 (n=43,43,51,51) | 3.55 units on scale | Standard Error 0.21 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 11 (n=43,43,52,52) | 3.53 units on scale | Standard Error 0.22 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pigmentation: Week 8 (n=43,43,51,51) | 3.43 units on scale | Standard Error 0.19 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 18 (n=40,40,52,52) | 4.39 units on scale | Standard Error 0.29 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 11 (n=43,43,52,52) | 3.76 units on scale | Standard Error 0.22 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 24 (n=43,43,53,53) | 3.55 units on scale | Standard Error 0.27 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 18 (n=40,40,52,52) | 3.84 units on scale | Standard Error 0.26 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 11 (n=43,43,52,52) | 3.91 units on scale | Standard Error 0.24 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 18 (n=40,40,52,52) | 4.32 units on scale | Standard Error 0.25 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 11 (n=43,43,52,52) | 3.83 units on scale | Standard Error 0.25 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Vascularity: Week 8 (n=43,43,51,51) | 3.79 units on scale | Standard Error 0.24 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 8 (n=43,43,51,51) | 3.56 units on scale | Standard Error 0.22 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Surface Area: Week 24 (n=43,43,53,53) | 4.78 units on scale | Standard Error 0.27 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 11(n=43,43,52,52) | 3.65 units on scale | Standard Error 0.24 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 24 (n=43,43,53,53) | 4.53 units on scale | Standard Error 0.27 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 8 (n=43,43,51,51) | 3.55 units on scale | Standard Error 0.21 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 18 (n=40,40,52,52) | 4.08 units on scale | Standard Error 0.28 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Relief: Week 11(n=43,43,52,52) | 3.70 units on scale | Standard Error 0.25 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Overall Opinion: Week 18 (n=40,40,52,52) | 4.47 units on scale | Standard Error 0.27 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Pliability: Week 18 (n=40,40,52,52) | 3.84 units on scale | Standard Error 0.26 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 24 (n=43,43,53,53) | 4.77 units on scale | Standard Error 0.3 |
| Group 2: Placebo 3* 5 mg/cm | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Thickness: Week 11(n=43,43,52,52) | 3.82 units on scale | Standard Error 0.24 |
Comparison: Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.23, 0.69]
Comparison: Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.02, 1]
Comparison: Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.53, 0.23]
Comparison: Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.08, 1.2]
Comparison: Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.44, 0.42]
Comparison: Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.43, 0.2]
Comparison: Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.43, 0.11]
Comparison: Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.15, 0.52]
Comparison: Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.22, 0.36]
Comparison: Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.07, 0.77]
Comparison: Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.05, 0.65]
Comparison: Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.03, 0.68]
Comparison: Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.09, 0.52]
Comparison: Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.18, 0.42]
Comparison: Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.09, 1.28]
Comparison: Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.35, 0.22]
Comparison: Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.47, 0.24]
Comparison: Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.6, 0.06]
Comparison: Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.35, 0.41]
Comparison: Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.33, 0.37]
Comparison: Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.24, 0.53]
Comparison: Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.39, 0.32]
Comparison: Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.22, 0.58]
Comparison: Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.42, 0.35]
Comparison: Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.05, 0.84]
Comparison: Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.62, 0.23]
Comparison: Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.4, 1.49]
Comparison: Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.3, 0.72]
Comparison: Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.13, 1.24]
Comparison: Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.38, 0.67]
Comparison: Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.01, 0.78]
Comparison: Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.5, 0.28]
Comparison: Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.23, 0.67]
Comparison: Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.63, 0.24]
Comparison: Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.21, 1.26]
Comparison: Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.41, 0.59]
Comparison: Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.02, 1.02]
Comparison: Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.33, 0.63]
Comparison: Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.09, 0.67]
Comparison: Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.39, 0.34]
Comparison: Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.12, 0.74]
Comparison: Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.76, 0.05]
Comparison: Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.25, 1.2]
Comparison: Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.46, 0.42]
Comparison: Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0.01, 1.05]
Comparison: Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [0, 0.98]
Comparison: Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.29, 0.62]
Comparison: Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-0647387190% CI: [-0.28, 0.43]
Comparison: Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.277890% CI: [-0.12, 0.6]Repeated measures model
Comparison: Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.688890% CI: [-0.28, 0.45]Repeated measures model
Comparison: Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.351590% CI: [-0.18, 0.65]Repeated measures model
Comparison: Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.378890% CI: [-0.64, 0.19]Repeated measures model
Comparison: Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.004490% CI: [0.35, 1.29]Repeated measures model
Comparison: Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.p-value: 0.684890% CI: [-0.35, 0.58]Repeated measures model
Other Pre-specified
Number of Participants With Abnormal Physical Examinations
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.
Time frame: Baseline up to Week 24
Population: Safety population included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Abnormal Physical Examinations | 0 participants | 0.39 |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Abnormal Physical Examinations | 0 participants | 0.37 |
Other Pre-specified
Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.
Time frame: Baseline up to Week 24
Population: Safety population included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 participants | 0.39 |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 participants | 0.37 |
Other Pre-specified
Number of Participants With Electrocardiogram Findings
Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.
Time frame: Baseline, Week 11
Population: Safety population included all participants who received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Baseline: Normal (n=45,55) | 38 participants | 0.39 |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Baseline: Abnormal, NCS (n=45,55) | 7 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Baseline: Abnormal , CS (n=45,55) | 0 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Week 11: Normal (n=42,53) | 33 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Week 11: Abnormal, NCS (n=42,53) | 9 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Week 11: Abnormal, CS (n=42,53) | 0 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Week 11: Abnormal, NCS (n=42,53) | 10 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Baseline: Normal (n=45,55) | 43 participants | 0.37 |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Week 11: Normal (n=42,53) | 43 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Baseline: Abnormal, NCS (n=45,55) | 12 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Week 11: Abnormal, CS (n=42,53) | 0 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Electrocardiogram Findings | Baseline: Abnormal , CS (n=45,55) | 0 participants | — |
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest
Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.
Time frame: Baseline up to Week 24
Population: Safety population included all participants who received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest | 3 participants | 0.39 |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest | 9 participants | 0.37 |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.
Time frame: Baseline up to Week 24
Population: Safety population included all participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Leukopenia | 0 participants | 0.39 |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Hyperbilrubinemia | 0 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Amylase increased | 1 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Blood creatine phosphokinase (CPK) increased | 2 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Blood glucose increased | 0 participants | — |
| Group 1: PF-06473871: 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Blood lactate dehydrogenase (LDH) increased | 0 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Blood glucose increased | 1 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Leukopenia | 1 participants | 0.37 |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Blood creatine phosphokinase (CPK) increased | 6 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Hyperbilrubinemia | 1 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Blood lactate dehydrogenase (LDH) increased | 1 participants | — |
| Group 1: Placebo 4* 5 mg/cm | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | Amylase increased | 1 participants | — |