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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01346969
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : September 9, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Reduction in Hypertrophic Skin Scarring
Intervention Drug: EXC 001
Enrollment 68
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.
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group Description Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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. 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. 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. 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.
Period Title: Overall Study
Started 28 14 13 13
Safety Population 27 14 13 13
Completed 26 14 10 12
Not Completed 2 0 3 1
Reason Not Completed
Withdrawal by Subject             0             0             1             0
Lost to Follow-up             1             0             2             0
Physician Decision             0             0             0             1
Randomized but not treated             1             0             0             0
Arm/Group Title 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
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 26 14 11 12 63
Hide Baseline Analysis Population Description
Analysis population was defined as all participants that have missed no more than 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 14 participants 11 participants 12 participants 63 participants
38.7  (10.9) 43.2  (7.16) 40.1  (13.29) 38.4  (8.22) 39.9  (10.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 14 participants 11 participants 12 participants 63 participants
Female
26
 100.0%
14
 100.0%
11
 100.0%
11
  91.7%
62
  98.4%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   1.6%
1.Primary Outcome
Title Physician Observer Scar Assessment Score at Week 24
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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
Hide Arm/Group Description:
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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.
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.
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.
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.
Overall Number of Participants Analyzed 26 14 10 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Opinion 0.0  (1.92) -0.5  (2.31) 0.8  (1.87) -0.3  (1.97)
Vascularity 0.0  (1.70) -0.6  (1.91) 0.9  (1.52) -0.2  (1.64)
Pigmentation -0.3  (1.41) -0.4  (2.10) 0.7  (1.42) -0.3  (1.36)
Thickness 0.2  (2.41) -0.6  (2.38) 0.8  (2.04) -0.2  (1.90)
Relief 0.0  (2.24) -0.4  (1.95) 0.7  (2.36) -0.2  (1.90)
Pliability 0.2  (1.99) -0.6  (2.27) 0.6  (1.71) -0.4  (1.62)
Surface Area 0.1  (1.75) -0.4  (2.85) 0.6  (1.90) -0.1  (2.15)
Composite Score 0.2  (10.53) -3.1  (12.60) 4.3  (9.76) -1.3  (8.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Overall Opinion: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.8 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Vascularity: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Pigmentation: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.391
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.0 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Thickness: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.696
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Relief: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Pliability: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.693
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Surface Area: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.770
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.7 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm
Comments Composite Score: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.938
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-3.7 to 4.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Overall Opinion: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.340
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.5 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Vascularity: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.6 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Pigmentation: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.4 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Thickness: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.287
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.6 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Relief: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.420
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.5 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Pliability: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.7 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Surface Area: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.427
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.5 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 2 mg/cm and Placebo
Comments Composite Score: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.256
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-8.4 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Overall Opinion: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.4 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Vascularity: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.132
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-0.3 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Pigmentation: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.4 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Thickness: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.208
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.4 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Relief: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.265
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.5 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Pliability: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.340
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.6 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Surface Area: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.347
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.7 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Comments Composite Score: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-2.0 to 10.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Overall Opinion: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.4 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Vascularity: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.760
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.2 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Pigmentation: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.636
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.3 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Thickness: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.774
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.3 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Relief: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.3 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Pliability: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.468
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.5 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Surface Area: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.886
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.2 to 1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection EXC 001 (PF-06473871) 5 mg/cm and Placebo
Comments Composite Score: Intraparticipant analysis
Type of Statistical Test Other
Comments LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-7.0 to 4.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.91
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Physician Observer Scar Assessment Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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
Hide Arm/Group Description:
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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.
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.
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.
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.
Overall Number of Participants Analyzed 26 14 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 11, Overall Opinion Number Analyzed 26 participants 12 participants 11 participants 12 participants
-0.3  (2.27) -0.6  (2.07) 0.2  (2.04) 0.3  (1.54)
Week 11, Vascularity Number Analyzed 26 participants 12 participants 11 participants 12 participants
0.0  (2.12) -0.2  (1.70) 0.1  (1.38) 0.0  (1.21)
Week 11, Pigmentation Number Analyzed 26 participants 12 participants 11 participants 12 participants
-0.5  (1.88) -0.1  (1.78) 0.4  (1.50) 0.0  (1.54)
Week 11, Thickness Number Analyzed 26 participants 12 participants 11 participants 12 participants
-0.4  (2.18) -0.1  (2.15) 0.2  (1.99) -0.2  (1.85)
Week 11, Relief Number Analyzed 26 participants 12 participants 11 participants 12 participants
-0.4  (2.00) -0.3  (2.05) 0.0  (2.28) 0.0  (2.26)
Week 11, Pliability Number Analyzed 26 participants 12 participants 11 participants 12 participants
-0.4  (2.40) -0.2  (2.29) -0.2  (2.27) -0.3  (1.76)
Week 11, Surface Area Number Analyzed 26 participants 12 participants 11 participants 12 participants
-0.4  (2.14) -0.3  (2.27) 0.1  (1.04) 0.3  (1.82)
Week 11, Composite Score Number Analyzed 26 participants 12 participants 11 participants 12 participants
-2.1  (11.46) -1.1  (11.19) 0.5  (9.75) -0.2  (8.57)
Week 18, Overall Opinion Number Analyzed 26 participants 14 participants 11 participants 11 participants
0.1  (2.07) -0.7  (2.43) 0.3  (2.05) 0.4  (2.25)
Week 18, Vascularity Number Analyzed 26 participants 14 participants 11 participants 11 participants
0.3  (1.51) -0.6  (2.24) -0.1  (1.97) 0.5  (1.57)
Week 18, Pigmentation Number Analyzed 26 participants 14 participants 11 participants 11 participants
-0.2  (1.49) -0.6  (2.34) 0.3  (1.56) 0.0  (1.79)
Week 18, Thickness Number Analyzed 26 participants 14 participants 11 participants 11 participants
-0.1  (2.24) -0.4  (2.28) 0.5  (1.97) 0.6  (2.29)
Week 18, Relief Number Analyzed 26 participants 14 participants 11 participants 11 participants
0.2  (2.41) -0.3  (2.49) 0.5  (1.86) 0.5  (2.21)
Week 18, Pliability Number Analyzed 26 participants 14 participants 11 participants 11 participants
0.2  (2.19) -0.7  (2.52) 0.5  (1.21) 0.7  (2.24)
Week 18, Surface Area Number Analyzed 26 participants 14 participants 11 participants 11 participants
-0.1  (2.28) -0.4  (2.50) 0.4  (1.75) 0.2  (2.40)
Week 18, Composite Score Number Analyzed 26 participants 14 participants 11 participants 11 participants
0.4  (10.45) -3.1  (13.44) 2.1  (9.45) 2.5  (11.21)
3.Secondary Outcome
Title Expert Panel Scar Assessment Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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
Hide Arm/Group Description:
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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.
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.
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.
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.
Overall Number of Participants Analyzed 26 14 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 11 Number Analyzed 26 participants 13 participants 11 participants 12 participants
2.0  (14.67) 0.4  (15.89) 3.7  (13.18) -4.1  (13.71)
Week 18 Number Analyzed 26 participants 14 participants 11 participants 12 participants
2.2  (14.70) -2.7  (13.54) 9.5  (14.28) -2.1  (15.94)
Week 24 Number Analyzed 26 participants 14 participants 10 participants 12 participants
4.1  (15.94) -2.5  (17.78) 6.5  (15.38) -1.5  (15.43)
4.Secondary Outcome
Title Subject Observer Scar Assessment Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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
Hide Arm/Group Description:
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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.
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.
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.
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.
Overall Number of Participants Analyzed 26 14 10 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Opinion -0.1  (2.47) 0.0  (2.22) 1.2  (2.35) -0.2  (2.55)
Pain -0.2  (2.25) 0.2  (0.89) 0.3  (0.95) -0.1  (0.51)
Itching 0.0  (1.11) 0.1  (0.86) 0.3  (0.95) -0.3  (0.65)
Color -0.5  (1.58) -0.1  (1.82) 0.6  (1.17) 0.3  (2.05)
Stiffness -0.4  (1.68) 0.1  (2.06) 0.4  (2.22) -0.1  (3.00)
Thickness -0.2  (2.22) 0.0  (1.36) 0.7  (2.41) 0.2  (3.19)
Irregular -0.3  (1.96) -0.1  (1.96) 0.7  (2.58) 0.0  (3.05)
Composite Score -1.7  (9.03) 0.2  (6.80) 3.0  (8.52) -0.1  (11.34)
Scar Appearance Composite Score -1.5  (6.77) -0.1  (6.44) 2.4  (7.68) 0.3  (10.71)
5.Secondary Outcome
Title Number of Participants With Physician Photonumeric Guide Scar Assessment Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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
Hide Arm/Group Description:
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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.
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.
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.
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.
Overall Number of Participants Analyzed 26 14 10 12
Measure Type: Count of Participants
Unit of Measure: Participants
4 times EXC 001, minimal
10
  38.5%
4
  28.6%
1
  10.0%
0
   0.0%
4 times EXC 001, mild
6
  23.1%
3
  21.4%
5
  50.0%
7
  58.3%
4 times EXC 001, moderate
3
  11.5%
3
  21.4%
3
  30.0%
1
   8.3%
4 times EXC 001, severe
6
  23.1%
3
  21.4%
0
   0.0%
2
  16.7%
4 times EXC 001, very severe
1
   3.8%
1
   7.1%
1
  10.0%
2
  16.7%
3 times EXC 001/Placebo, minimal
7
  26.9%
2
  14.3%
6
  60.0%
4
  33.3%
3 times EXC 001/Placebo, mild
13
  50.0%
5
  35.7%
1
  10.0%
0
   0.0%
3 times EXC 001/Placebo, moderate
2
   7.7%
2
  14.3%
1
  10.0%
3
  25.0%
3 times EXC 001/Placebo, severe
3
  11.5%
4
  28.6%
2
  20.0%
4
  33.3%
3 times EXC 001/Placebo, very severe
1
   3.8%
1
   7.1%
0
   0.0%
1
   8.3%
6.Secondary Outcome
Title Number of Participants With Participant Photonumeric Guide Scar Assessment Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 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
Hide Arm/Group Description:
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (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.
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.
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.
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.
Overall Number of Participants Analyzed 26 13 10 12
Measure Type: Count of Participants
Unit of Measure: Participants
4 times EXC 001, minimal
8
  30.8%
1
   7.7%
1
  10.0%
1
   8.3%
4 times EXC 001, mild
8
  30.8%
1
   7.7%
4
  40.0%
4
  33.3%
4 times EXC 001, moderate
2
   7.7%
4
  30.8%
3
  30.0%
4
  33.3%
4 times EXC 001, severe
7
  26.9%
5
  38.5%
1
  10.0%
2
  16.7%
4 times EXC 001, very severe
1
   3.8%
2
  15.4%
1
  10.0%
1
   8.3%
3 times EXC 001/Placebo, minimal
4
  15.4%
1
   7.7%
4
  40.0%
2
  16.7%
3 times EXC 001/Placebo, mild
13
  50.0%
3
  23.1%
2
  20.0%
3
  25.0%
3 times EXC 001/Placebo, moderate
4
  15.4%
4
  30.8%
1
  10.0%
2
  16.7%
3 times EXC 001/Placebo, severe
4
  15.4%
3
  23.1%
1
  10.0%
4
  33.3%
3 times EXC 001/Placebo, very severe
1
   3.8%
2
  15.4%
2
  20.0%
1
   8.3%
Time Frame Day 1 up to Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/14 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/27 (48.15%)   2/14 (14.29%)   2/13 (15.38%)   3/13 (23.08%) 
Gastrointestinal disorders         
Nausea * 1  2/27 (7.41%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Toothache * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Vomiting * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
General disorders         
Application site rash * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Impaired healing * 1  0/27 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Influenza like illness * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Injection site erythema * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Oedema peripheral * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Immune system disorders         
Hypersensitivity * 1  0/27 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Infections and infestations         
Cellulitis * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Eye infection * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Fungal infection * 1  0/27 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Labyrinthitis * 1  0/27 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%) 
Lyme disease * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Pharyngitis streptococcal * 1  0/27 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%) 
Sinusitis * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Upper respiratory tract infection * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Urinary tract infection * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Procedural pain * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Procedural site reaction * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia * 1  0/27 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%) 
Vitamin D deficiency * 1  0/27 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Neck pain * 1  0/27 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Uterine leiomyoma * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Nervous system disorders         
Headache * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Nerve compression * 1  0/27 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Reproductive system and breast disorders         
Breast induration * 1  0/27 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Pelvic pain * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Vulvovaginal discomfort * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Nasal congestion * 1  1/27 (3.70%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%) 
Oropharyngeal pain * 1  0/27 (0.00%)  1/14 (7.14%)  1/13 (7.69%)  0/13 (0.00%) 
Cough * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders         
Acne * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
Dermatitis * 1  0/27 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Rash * 1  0/27 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Scar pain * 1  0/27 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%) 
Vascular disorders         
Hypertension * 1  1/27 (3.70%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01346969    
Other Study ID Numbers: EXC 001-204
B5301004 ( Other Identifier: Alias Study Number )
First Submitted: May 1, 2011
First Posted: May 4, 2011
Results First Submitted: June 14, 2021
Results First Posted: September 9, 2021
Last Update Posted: September 9, 2021