Reduction in Hypertrophic Skin Scarring
Conditions
Keywords
Skin scarring, cicatrix, breast scar
Brief summary
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
Interventions
DRUGEXC 001
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have previous had breast surgery resulting in unacceptable scars. * Subject has chosen to have breast scars revised. * Subject 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 the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Observer Scar Assessment Score at Week 24 | Week 24 | Physician 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 scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. 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 lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Observer Scar Assessment Score | Week 11, 18 | Physician observer scar assessment score 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 lower scores indicated better outcome. 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 lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received. |
| Expert Panel Scar Assessment Score | Week 11, 18, 24 | Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the worse scar and then rated the other scar. The difference between these two ratings was the improvement of scar severity. If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair. |
| Subject Observer Scar Assessment Score | Week 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). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome. |
| Number of Participants With Physician Photonumeric Guide Scar Assessment Score | Week 24 | Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times). |
| Number of Participants With Participant Photonumeric Guide Scar Assessment Score | Week 24 | Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times). |
Countries
United States
Participant flow
Recruitment details
Participants who previously had breast surgery resulting in unacceptable bilateral scars and had chosen to have the breast scars revised were recruited in this study.
Participants by arm
| Arm | Count |
|---|---|
| EXC 001 (PF-06473871) 5 mg/cm Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast. | 26 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. | 14 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. | 11 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. | 12 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Randomized but not treated | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | EXC 001 (PF-06473871) 5 mg/cm | EXC 001 (PF-06473871) 2 mg/cm and Placebo | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.7 years STANDARD_DEVIATION 10.9 | 43.2 years STANDARD_DEVIATION 7.16 | 40.1 years STANDARD_DEVIATION 13.29 | 38.4 years STANDARD_DEVIATION 8.22 | 39.9 years STANDARD_DEVIATION 10.13 |
| Sex: Female, Male Female | 26 Participants | 14 Participants | 11 Participants | 11 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 27 | 2 / 14 | 2 / 13 | 3 / 13 |
| serious Total, serious adverse events | 0 / 27 | 0 / 14 | 0 / 13 | 0 / 13 |
Outcome results
Primary
Physician Observer Scar Assessment Score at Week 24
Physician 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 scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. 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 lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Time frame: Week 24
Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Overall Opinion | 0.0 units on a scale | Standard Deviation 1.92 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Vascularity | 0.0 units on a scale | Standard Deviation 1.7 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Pigmentation | -0.3 units on a scale | Standard Deviation 1.41 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Thickness | 0.2 units on a scale | Standard Deviation 2.41 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Relief | 0.0 units on a scale | Standard Deviation 2.24 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Pliability | 0.2 units on a scale | Standard Deviation 1.99 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Surface Area | 0.1 units on a scale | Standard Deviation 1.75 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score at Week 24 | Composite Score | 0.2 units on a scale | Standard Deviation 10.53 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Pliability | -0.6 units on a scale | Standard Deviation 2.27 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Relief | -0.4 units on a scale | Standard Deviation 1.95 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Vascularity | -0.6 units on a scale | Standard Deviation 1.91 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Composite Score | -3.1 units on a scale | Standard Deviation 12.6 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Surface Area | -0.4 units on a scale | Standard Deviation 2.85 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Thickness | -0.6 units on a scale | Standard Deviation 2.38 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Pigmentation | -0.4 units on a scale | Standard Deviation 2.1 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Overall Opinion | -0.5 units on a scale | Standard Deviation 2.31 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Surface Area | 0.6 units on a scale | Standard Deviation 1.9 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Pigmentation | 0.7 units on a scale | Standard Deviation 1.42 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Thickness | 0.8 units on a scale | Standard Deviation 2.04 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Relief | 0.7 units on a scale | Standard Deviation 2.36 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Pliability | 0.6 units on a scale | Standard Deviation 1.71 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Composite Score | 4.3 units on a scale | Standard Deviation 9.76 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Overall Opinion | 0.8 units on a scale | Standard Deviation 1.87 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Vascularity | 0.9 units on a scale | Standard Deviation 1.52 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Pigmentation | -0.3 units on a scale | Standard Deviation 1.36 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Thickness | -0.2 units on a scale | Standard Deviation 1.9 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Vascularity | -0.2 units on a scale | Standard Deviation 1.64 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Overall Opinion | -0.3 units on a scale | Standard Deviation 1.97 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Relief | -0.2 units on a scale | Standard Deviation 1.9 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Composite Score | -1.3 units on a scale | Standard Deviation 8.67 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Surface Area | -0.1 units on a scale | Standard Deviation 2.15 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score at Week 24 | Pliability | -0.4 units on a scale | Standard Deviation 1.62 |
Comparison: Overall Opinion: Intraparticipant analysisp-value: 195% CI: [-0.8, 0.8]Mixed Models Analysis
Comparison: Vascularity: Intraparticipant analysisp-value: 195% CI: [-0.7, 0.7]Mixed Models Analysis
Comparison: Pigmentation: Intraparticipant analysisp-value: 0.39195% CI: [-1, 0.4]Mixed Models Analysis
Comparison: Thickness: Intraparticipant analysisp-value: 0.69695% CI: [-0.6, 0.9]Mixed Models Analysis
Comparison: Relief: Intraparticipant analysisp-value: 0.92195% CI: [-0.7, 0.8]Mixed Models Analysis
Comparison: Pliability: Intraparticipant analysisp-value: 0.69395% CI: [-0.6, 0.9]Mixed Models Analysis
Comparison: Surface Area: Intraparticipant analysisp-value: 0.7795% CI: [-0.7, 0.9]Mixed Models Analysis
Comparison: Composite Score: Intraparticipant analysisp-value: 0.93895% CI: [-3.7, 4]Mixed Models Analysis
Comparison: Overall Opinion: Intraparticipant analysisp-value: 0.3495% CI: [-1.5, 0.5]Mixed Models Analysis
Comparison: Vascularity: Intraparticipant analysisp-value: 0.25895% CI: [-1.6, 0.4]Mixed Models Analysis
Comparison: Pigmentation: Intraparticipant analysisp-value: 0.38195% CI: [-1.4, 0.5]Mixed Models Analysis
Comparison: Thickness: Intraparticipant analysisp-value: 0.28795% CI: [-1.6, 0.5]Mixed Models Analysis
Comparison: Relief: Intraparticipant analysisp-value: 0.4295% CI: [-1.5, 0.6]Mixed Models Analysis
Comparison: Pliability: Intraparticipant analysisp-value: 0.22795% CI: [-1.7, 0.4]Mixed Models Analysis
Comparison: Surface Area: Intraparticipant analysisp-value: 0.42795% CI: [-1.5, 0.6]Mixed Models Analysis
Comparison: Composite Score: Intraparticipant analysisp-value: 0.25695% CI: [-8.4, 2.2]Mixed Models Analysis
Comparison: Overall Opinion: Intraparticipant analysisp-value: 0.19895% CI: [-0.4, 2]Mixed Models Analysis
Comparison: Vascularity: Intraparticipant analysisp-value: 0.13295% CI: [-0.3, 2.1]Mixed Models Analysis
Comparison: Pigmentation: Intraparticipant analysisp-value: 0.22795% CI: [-0.4, 1.8]Mixed Models Analysis
Comparison: Thickness: Intraparticipant analysisp-value: 0.20895% CI: [-0.4, 2]Mixed Models Analysis
Comparison: Relief: Intraparticipant analysisp-value: 0.26595% CI: [-0.5, 1.9]Mixed Models Analysis
Comparison: Pliability: Intraparticipant analysisp-value: 0.3495% CI: [-0.6, 1.8]Mixed Models Analysis
Comparison: Surface Area: Intraparticipant analysisp-value: 0.34795% CI: [-0.7, 1.9]Mixed Models Analysis
Comparison: Composite Score: Intraparticipant analysisp-value: 0.17995% CI: [-2, 10.6]Mixed Models Analysis
Comparison: Overall Opinion: Intraparticipant analysisp-value: 0.55695% CI: [-1.4, 0.8]Mixed Models Analysis
Comparison: Vascularity: Intraparticipant analysisp-value: 0.7695% CI: [-1.2, 0.9]Mixed Models Analysis
Comparison: Pigmentation: Intraparticipant analysisp-value: 0.63695% CI: [-1.3, 0.8]Mixed Models Analysis
Comparison: Thickness: Intraparticipant analysisp-value: 0.77495% CI: [-1.3, 1]Mixed Models Analysis
Comparison: Relief: Intraparticipant analysisp-value: 0.77195% CI: [-1.3, 1]Mixed Models Analysis
Comparison: Pliability: Intraparticipant analysisp-value: 0.46895% CI: [-1.5, 0.7]Mixed Models Analysis
Comparison: Surface Area: Intraparticipant analysisp-value: 0.88695% CI: [-1.2, 1.1]Mixed Models Analysis
Comparison: Composite Score: Intraparticipant analysisp-value: 0.66895% CI: [-7, 4.5]Mixed Models Analysis
Secondary
Expert Panel Scar Assessment Score
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the worse scar and then rated the other scar. The difference between these two ratings was the improvement of scar severity. If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.
Time frame: Week 11, 18, 24
Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 (PF-06473871) 5 mg/cm | Expert Panel Scar Assessment Score | Week 11 | 2.0 units on a scale | Standard Deviation 14.67 |
| EXC 001 (PF-06473871) 5 mg/cm | Expert Panel Scar Assessment Score | Week 24 | 4.1 units on a scale | Standard Deviation 15.94 |
| EXC 001 (PF-06473871) 5 mg/cm | Expert Panel Scar Assessment Score | Week 18 | 2.2 units on a scale | Standard Deviation 14.7 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 11 | 0.4 units on a scale | Standard Deviation 15.89 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 24 | -2.5 units on a scale | Standard Deviation 17.78 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 18 | -2.7 units on a scale | Standard Deviation 13.54 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 18 | 9.5 units on a scale | Standard Deviation 14.28 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 11 | 3.7 units on a scale | Standard Deviation 13.18 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 24 | 6.5 units on a scale | Standard Deviation 15.38 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 11 | -4.1 units on a scale | Standard Deviation 13.71 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 24 | -1.5 units on a scale | Standard Deviation 15.43 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Expert Panel Scar Assessment Score | Week 18 | -2.1 units on a scale | Standard Deviation 15.94 |
Secondary
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Time frame: Week 24
Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 8 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 8 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 7 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 4 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 13 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 4 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 4 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 1 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 4 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 3 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 5 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 2 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 1 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 3 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 2 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 4 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 1 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 2 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 2 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 4 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 4 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 3 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 3 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 4 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 4 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 4 Participants |
Secondary
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Time frame: Week 24
Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 10 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 6 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 3 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 6 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 7 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 13 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 3 Participants |
| EXC 001 (PF-06473871) 5 mg/cm | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 1 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 3 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 4 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 3 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 1 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 2 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 5 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 1 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 2 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 4 Participants |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 3 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 0 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 0 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 6 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 2 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 5 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 1 Participants |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 3 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, very severe | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, moderate | 3 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, minimal | 4 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, very severe | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, mild | 0 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, mild | 7 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, moderate | 1 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, severe | 2 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 4 times EXC 001, minimal | 0 Participants |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 3 times EXC 001/Placebo, severe | 4 Participants |
Secondary
Physician Observer Scar Assessment Score
Physician observer scar assessment score 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 lower scores indicated better outcome. 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 lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Time frame: Week 11, 18
Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Relief | -0.4 units on a scale | Standard Deviation 2 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Vascularity | 0.0 units on a scale | Standard Deviation 2.12 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Pigmentation | -0.5 units on a scale | Standard Deviation 1.88 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Thickness | -0.4 units on a scale | Standard Deviation 2.18 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Overall Opinion | -0.3 units on a scale | Standard Deviation 2.27 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Pliability | -0.4 units on a scale | Standard Deviation 2.4 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Surface Area | -0.4 units on a scale | Standard Deviation 2.14 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 11, Composite Score | -2.1 units on a scale | Standard Deviation 11.46 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Overall Opinion | 0.1 units on a scale | Standard Deviation 2.07 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Vascularity | 0.3 units on a scale | Standard Deviation 1.51 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Pigmentation | -0.2 units on a scale | Standard Deviation 1.49 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Thickness | -0.1 units on a scale | Standard Deviation 2.24 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Relief | 0.2 units on a scale | Standard Deviation 2.41 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Pliability | 0.2 units on a scale | Standard Deviation 2.19 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Surface Area | -0.1 units on a scale | Standard Deviation 2.28 |
| EXC 001 (PF-06473871) 5 mg/cm | Physician Observer Scar Assessment Score | Week 18, Composite Score | 0.4 units on a scale | Standard Deviation 10.45 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Pliability | -0.2 units on a scale | Standard Deviation 2.29 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Overall Opinion | -0.7 units on a scale | Standard Deviation 2.43 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Composite Score | -3.1 units on a scale | Standard Deviation 13.44 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Thickness | -0.4 units on a scale | Standard Deviation 2.28 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Surface Area | -0.4 units on a scale | Standard Deviation 2.5 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Vascularity | -0.6 units on a scale | Standard Deviation 2.24 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Pigmentation | -0.1 units on a scale | Standard Deviation 1.78 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Pigmentation | -0.6 units on a scale | Standard Deviation 2.34 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Relief | -0.3 units on a scale | Standard Deviation 2.05 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Surface Area | -0.3 units on a scale | Standard Deviation 2.27 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Thickness | -0.1 units on a scale | Standard Deviation 2.15 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Vascularity | -0.2 units on a scale | Standard Deviation 1.7 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Relief | -0.3 units on a scale | Standard Deviation 2.49 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Composite Score | -1.1 units on a scale | Standard Deviation 11.19 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Pliability | -0.7 units on a scale | Standard Deviation 2.52 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Overall Opinion | -0.6 units on a scale | Standard Deviation 2.07 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Pliability | -0.2 units on a scale | Standard Deviation 2.27 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Relief | 0.0 units on a scale | Standard Deviation 2.28 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Pliability | 0.5 units on a scale | Standard Deviation 1.21 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Surface Area | 0.1 units on a scale | Standard Deviation 1.04 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Composite Score | 0.5 units on a scale | Standard Deviation 9.75 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Composite Score | 2.1 units on a scale | Standard Deviation 9.45 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Overall Opinion | 0.3 units on a scale | Standard Deviation 2.05 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Vascularity | -0.1 units on a scale | Standard Deviation 1.97 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Surface Area | 0.4 units on a scale | Standard Deviation 1.75 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Pigmentation | 0.3 units on a scale | Standard Deviation 1.56 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Thickness | 0.5 units on a scale | Standard Deviation 1.97 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Overall Opinion | 0.2 units on a scale | Standard Deviation 2.04 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Vascularity | 0.1 units on a scale | Standard Deviation 1.38 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Relief | 0.5 units on a scale | Standard Deviation 1.86 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Pigmentation | 0.4 units on a scale | Standard Deviation 1.5 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Thickness | 0.2 units on a scale | Standard Deviation 1.99 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Composite Score | 2.5 units on a scale | Standard Deviation 11.21 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Composite Score | -0.2 units on a scale | Standard Deviation 8.57 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Pigmentation | 0.0 units on a scale | Standard Deviation 1.54 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Overall Opinion | 0.3 units on a scale | Standard Deviation 1.54 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Pliability | 0.7 units on a scale | Standard Deviation 2.24 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Surface Area | 0.3 units on a scale | Standard Deviation 1.82 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Relief | 0.5 units on a scale | Standard Deviation 2.21 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Vascularity | 0.0 units on a scale | Standard Deviation 1.21 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Relief | 0.0 units on a scale | Standard Deviation 2.26 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Vascularity | 0.5 units on a scale | Standard Deviation 1.57 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Pliability | -0.3 units on a scale | Standard Deviation 1.76 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Pigmentation | 0.0 units on a scale | Standard Deviation 1.79 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Surface Area | 0.2 units on a scale | Standard Deviation 2.4 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Overall Opinion | 0.4 units on a scale | Standard Deviation 2.25 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 11, Thickness | -0.2 units on a scale | Standard Deviation 1.85 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Physician Observer Scar Assessment Score | Week 18, Thickness | 0.6 units on a scale | Standard Deviation 2.29 |
Secondary
Subject Observer Scar Assessment Score
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). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.
Time frame: Week 24
Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Irregular | -0.3 units on a scale | Standard Deviation 1.96 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Thickness | -0.2 units on a scale | Standard Deviation 2.22 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Scar Appearance Composite Score | -1.5 units on a scale | Standard Deviation 6.77 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Color | -0.5 units on a scale | Standard Deviation 1.58 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Itching | 0.0 units on a scale | Standard Deviation 1.11 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Pain | -0.2 units on a scale | Standard Deviation 2.25 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Composite Score | -1.7 units on a scale | Standard Deviation 9.03 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Stiffness | -0.4 units on a scale | Standard Deviation 1.68 |
| EXC 001 (PF-06473871) 5 mg/cm | Subject Observer Scar Assessment Score | Overall Opinion | -0.1 units on a scale | Standard Deviation 2.47 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Stiffness | 0.1 units on a scale | Standard Deviation 2.06 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Irregular | -0.1 units on a scale | Standard Deviation 1.96 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Thickness | 0.0 units on a scale | Standard Deviation 1.36 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Pain | 0.2 units on a scale | Standard Deviation 0.89 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Overall Opinion | 0.0 units on a scale | Standard Deviation 2.22 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Itching | 0.1 units on a scale | Standard Deviation 0.86 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Scar Appearance Composite Score | -0.1 units on a scale | Standard Deviation 6.44 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Composite Score | 0.2 units on a scale | Standard Deviation 6.8 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo | Subject Observer Scar Assessment Score | Color | -0.1 units on a scale | Standard Deviation 1.82 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Stiffness | 0.4 units on a scale | Standard Deviation 2.22 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Overall Opinion | 1.2 units on a scale | Standard Deviation 2.35 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Pain | 0.3 units on a scale | Standard Deviation 0.95 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Itching | 0.3 units on a scale | Standard Deviation 0.95 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Color | 0.6 units on a scale | Standard Deviation 1.17 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Thickness | 0.7 units on a scale | Standard Deviation 2.41 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Irregular | 0.7 units on a scale | Standard Deviation 2.58 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Composite Score | 3.0 units on a scale | Standard Deviation 8.52 |
| EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Subject Observer Scar Assessment Score | Scar Appearance Composite Score | 2.4 units on a scale | Standard Deviation 7.68 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Irregular | 0.0 units on a scale | Standard Deviation 3.05 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Color | 0.3 units on a scale | Standard Deviation 2.05 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Itching | -0.3 units on a scale | Standard Deviation 0.65 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Scar Appearance Composite Score | 0.3 units on a scale | Standard Deviation 10.71 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Composite Score | -0.1 units on a scale | Standard Deviation 11.34 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Pain | -0.1 units on a scale | Standard Deviation 0.51 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Thickness | 0.2 units on a scale | Standard Deviation 3.19 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Stiffness | -0.1 units on a scale | Standard Deviation 3 |
| EXC 001 (PF-06473871) 5 mg/cm and Placebo | Subject Observer Scar Assessment Score | Overall Opinion | -0.2 units on a scale | Standard Deviation 2.55 |