Trial Outcomes & Findings for Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery (NCT NCT01037413)

Last Updated: 2021-08-02

Results Overview

Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Part B: Week 12

Results posted on

2021-08-02

Participant Flow

Participants who elected to revise appearance of bilateral scars from previous breast surgery, were recruited in this study. Study had 2 parts- Part A and B. Participants with negative skin sensitization in Part A (skin testing) were assigned to Part B (scar revision surgery) of the study.

Safety assessment was not planned separately for EXC 001 (PF-0647387) and placebo. All participants acted as their own control receiving both EXC 001 and placebo on the same days during Part B of the study.

Participant milestones

Participant milestones
Measure	EXC 001 During Part A In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to scar revision surgery.	EXC 001 + Placebo During Part B Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear centimeter (cm) to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.
Part A: Skin Testing STARTED	25	0
Part A: Skin Testing COMPLETED	23	0
Part A: Skin Testing NOT COMPLETED	2	0
Part B: Scar Revision STARTED	0	23
Part B: Scar Revision Treated	0	22
Part B: Scar Revision COMPLETED	0	21
Part B: Scar Revision NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	EXC 001 During Part A In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to scar revision surgery.	EXC 001 + Placebo During Part B Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear centimeter (cm) to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.
Part A: Skin Testing Adverse Event	1	0
Part A: Skin Testing Protocol Violation	1	0
Part B: Scar Revision Withdrawal by Subject	0	1
Part B: Scar Revision Assigned But Not Treated	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Participants n=25 Participants All participants who were enrolled in the study.
Age, Continuous	41.4 years STANDARD_DEVIATION 8.77 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Part B: Week 12

Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Expert Panel Scar Assessment Score at Week 12	36.6 millimeter Standard Deviation 12.68	51.4 millimeter Standard Deviation 14.54	—

SECONDARY outcome

Timeframe: Part B: Week 8 and 24

Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score. Here 'Number Analyzed' signifies those participants who were evaluable at specified time-points.

Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Expert Panel Scar Assessment Score at Week 8 and 24 Week 8	34.7 millimeter Standard Deviation 11.18	49.4 millimeter Standard Deviation 13.96	—
Expert Panel Scar Assessment Score at Week 8 and 24 Week 24	30.7 millimeter Standard Deviation 13.55	56.7 millimeter Standard Deviation 22.56	—

SECONDARY outcome

Timeframe: Part B: Week 12 and 24

Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.

Physician observer assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1= normal skin to 10= worst scar imaginable, where higher scores indicate worse condition. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where higher scores indicate worse condition.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Vascularity	4.0 units on a scale Standard Deviation 1.75	5.2 units on a scale Standard Deviation 1.67	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Pigmentation	3.4 units on a scale Standard Deviation 1.33	4.6 units on a scale Standard Deviation 1.80	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Thickness	3.8 units on a scale Standard Deviation 1.58	5.4 units on a scale Standard Deviation 2.18	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Relief	3.4 units on a scale Standard Deviation 1.69	5.2 units on a scale Standard Deviation 2.47	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Pliability	3.6 units on a scale Standard Deviation 1.66	4.7 units on a scale Standard Deviation 2.15	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Surface Area	3.9 units on a scale Standard Deviation 1.53	5.3 units on a scale Standard Deviation 1.77	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Overall Opinion	3.7 units on a scale Standard Deviation 1.46	5.5 units on a scale Standard Deviation 1.83	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 12: Composite Score	22.1 units on a scale Standard Deviation 7.53	30.5 units on a scale Standard Deviation 10.42	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Vascularity	3.5 units on a scale Standard Deviation 1.29	5.8 units on a scale Standard Deviation 1.95	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Pigmentation	3.5 units on a scale Standard Deviation 1.21	5.4 units on a scale Standard Deviation 1.86	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Thickness	4.0 units on a scale Standard Deviation 1.82	5.8 units on a scale Standard Deviation 1.83	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Relief	3.2 units on a scale Standard Deviation 1.78	5.6 units on a scale Standard Deviation 2.29	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Pliability	3.2 units on a scale Standard Deviation 1.73	5.2 units on a scale Standard Deviation 2.34	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Surface Area	3.7 units on a scale Standard Deviation 1.71	5.9 units on a scale Standard Deviation 1.80	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Overall Opinion	3.6 units on a scale Standard Deviation 1.43	6.0 units on a scale Standard Deviation 1.70	—
Physician Observer Scar Assessment Score at Week 12 and 24 Week 24: Composite Score	21.0 units on a scale Standard Deviation 7.79	33.6 units on a scale Standard Deviation 10.11	—

SECONDARY outcome

Timeframe: Part B: Week 12 and 24

Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.

Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range =1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range =1 (no, same as normal skin) to 10 (yes, very different), where higher scores indicate worse condition. Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst), where higher scores indicate worse condition. Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst), where higher scores indicate worse condition.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B n=21 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Pain	2.0 units on a scale Standard Deviation 2.13	2.7 units on a scale Standard Deviation 1.93	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Itching	2.6 units on a scale Standard Deviation 2.82	3.0 units on a scale Standard Deviation 2.87	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Color	6.3 units on a scale Standard Deviation 3.07	6.8 units on a scale Standard Deviation 2.91	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Stiffness	4.0 units on a scale Standard Deviation 2.81	5.1 units on a scale Standard Deviation 3.42	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Thickness	4.4 units on a scale Standard Deviation 2.94	5.5 units on a scale Standard Deviation 2.96	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Irregular	4.6 units on a scale Standard Deviation 3.23	5.8 units on a scale Standard Deviation 3.11	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Overall Opinion	3.7 units on a scale Standard Deviation 1.90	4.8 units on a scale Standard Deviation 2.62	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Composite Score	24.0 units on a scale Standard Deviation 13.46	28.9 units on a scale Standard Deviation 13.79	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 12: Scar Appearance Composite Score	19.3 units on a scale Standard Deviation 10.95	23.3 units on a scale Standard Deviation 10.97	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Pain	1.5 units on a scale Standard Deviation 1.08	2.4 units on a scale Standard Deviation 2.36	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Itching	1.9 units on a scale Standard Deviation 2.00	2.5 units on a scale Standard Deviation 2.32	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Color	5.2 units on a scale Standard Deviation 3.14	7.0 units on a scale Standard Deviation 2.77	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Stiffness	3.6 units on a scale Standard Deviation 2.62	5.8 units on a scale Standard Deviation 3.33	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Thickness	3.6 units on a scale Standard Deviation 2.48	6.0 units on a scale Standard Deviation 3.26	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Irregular	4.3 units on a scale Standard Deviation 2.49	6.1 units on a scale Standard Deviation 3.20	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Overall Opinion	4.1 units on a scale Standard Deviation 2.48	6.5 units on a scale Standard Deviation 2.93	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Composite Score	20.1 units on a scale Standard Deviation 9.96	29.9 units on a scale Standard Deviation 13.80	—
Participant Observer Scar Assessment Score at Week 12 and 24 Week 24: Scar Appearance Composite Score	16.7 units on a scale Standard Deviation 9.37	24.9 units on a scale Standard Deviation 11.61	—

SECONDARY outcome

Timeframe: Part A: Day 1; Part B, Active Dosing: Week 2 up to Week 13; Part B, Post Dosing: Week 13 to end of the study (Week 24)

Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs and all non-SAEs that occurred during the study.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=25 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B n=22 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase n=22 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	9 Participants	16 Participants	3 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12

Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Here, "Number Analyzed" signifies number of participants evaluable for specified time points.

Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Abnormal physical examination findings was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=25 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Number of Participants With Abnormal Physical Examination Findings Screening	14 Participants	—	—
Number of Participants With Abnormal Physical Examination Findings Day 1 of Part B	3 Participants	—	—
Number of Participants With Abnormal Physical Examination Findings Week 12 of Part B	1 Participants	—	—

SECONDARY outcome

Timeframe: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12

Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=25 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Screening	0 Participants	—	—
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Part B: Week 12	0 Participants	—	—

SECONDARY outcome

Timeframe: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12

Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10\^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10\^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant findings were reported.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=25 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Number of Participants With Clinically Significant Findings in Laboratory Examinations Screening	0 Participants	—	—
Number of Participants With Clinically Significant Findings in Laboratory Examinations Part B: Day 1 up to Week 12	2 Participants	—	—

SECONDARY outcome

Timeframe: Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12

Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Clinical significance was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=25 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Number of Participants With Clinically Significant Findings in Vital Signs Screening	0 Participants	—	—
Number of Participants With Clinically Significant Findings in Vital Signs Part B: Day 1 up to Week 12	1 Participants	—	—

SECONDARY outcome

Timeframe: Part A: Day 1, Part B: Week 2 up to Week 24

Population: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.

Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appears to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions.

Outcome measures

Outcome measures
Measure	EXC 001 During Part B n=25 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast at Week 2, 5, 8, and 11 after the surgical incision was closed.	Placebo During Part B n=22 Participants Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Number of Participants With Positive Skin Sensitivity Reaction	0 Participants	0 Participants	—

Adverse Events

EXC 001 During Part A

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

EXC 001 + Placebo During Part B, Active Dosing Phase

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B, Post Dosing Phase

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EXC 001 During Part A n=25 participants at risk In Part A, participants received 2 intradermal injections of EXC 001 at a dose of 5 mg on Day 1 and 21, on lower back. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to scar revision surgery.	EXC 001 + Placebo During Part B, Active Dosing Phase n=22 participants at risk Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent scar revision surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of scar on one breast and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of scar on another breast (other breast than which received EXC 001), at Week 2, 5, 8, and 11 after the surgical incision was closed.	Part B, Post Dosing Phase n=22 participants at risk Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned and reported separately for EXC 001 and placebo.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned and reported separately for EXC 001 and placebo.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned and reported separately for EXC 001 and placebo.
Infections and infestations Bronchitis	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned and reported separately for EXC 001 and placebo.	4.5% 1/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned and reported separately for EXC 001 and placebo.	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned and reported separately for EXC 001 and placebo.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER