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| ID | Type | Description | Link |
|---|---|---|---|
| B5301009 | Other Identifier | Alias Study Number |
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This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXC 001 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXC 001 | Drug | Intradermal injections of EXC 001 and placebo given on various schedules. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Expert Panel Scar Assessment Score | Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13. | Week 13 of Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Physician Observer Global Assessment Scar Score | Physician observer global assessment of scar score was done using a valid published 10-point rating scale. Physicians rated severity of each scar on a scale of 1 = normal skin to 10 = worst scar imaginable. Each scar was given a single score and the differences in scores between the matched pairs of scars were calculated. There were 4 differences within each dose level that were averaged to create a single score for each participant at each dose level. The score was defined as the within participant average difference between EXC 001 and Placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University,Division of Plastic Surgery | Chicago | Illinois | 60611 | United States | ||
| Body Aesthetic Plastic Surgery |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Part B (incision wounds [IW] and abdominoplasty surgery): On Day 1, participants received 20 incisions (2 centimeters [cm] each), 10 incisions on either side of the midline (4 vertical columns of 4 incisions each, 2 columns of 2 incisions [lateral biomarker incisions]), on the abdominal area to be removed during abdominoplasty.
Participants who had chosen and qualified (had sufficient excess abdominal tissue) for a standard elective abdominoplasty were recruited in this study. The study was conducted in two-parts: Part A (Skin Testing Phase) and Part B (Active Dosing Phase). Participants with negative skin sensitization in Part A entered into Part B .
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: EXC 001 and Placebo | In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. |
| FG001 | Cohort 2: EXC 001 and Placebo | In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. |
| FG002 | Cohort 3: EXC 001 and Placebo | In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Skin Testing Phase (50 Days) |
|
| ||||||||||||||||||
| Part B: Active Dosing Phase (13 Weeks) |
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Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: EXC 001 and Placebo | In Part A participants received single intradermal injections of EXC-001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part B: Expert Panel Scar Assessment Score | Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13. | Completer population included all participants who missed not more than 1 dose of study drug, had the Week 13 assessment and non-missing data for VAS scar assessment score for at least one dose level. | Posted | Mean | Standard Deviation | millimeters | Week 13 of Part B |
|
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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 Part A Day 1 visit of and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Cohort 1: EXC 001 | Participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Intradermal injections of EXC 001 and placebo given on various schedules. |
|
| Week 13 of Part B |
| Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and weight. Number of participants with clinically significant change in any vital sign parameter compared to Baseline were reported. Criteria for clinically significant change in any vital sign parameter compared to baseline was based on investigator's discretion. | Part B: Day 1 up to Week 14 |
| Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings | Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Criteria for clinically significant findings in physical examination was based on investigator's discretion. | Part B: Day 1 up to Week 14 |
| Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings | Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's correction (QTc), heart rate (HR). A standard, single 12-lead ECG was taken and results was classified as normal, having a clinically insignificant abnormality, or having a clinically significant abnormality. Number of participants with clinically significant abnormality in ECG compared to baseline were reported. Criteria for clinically significant abnormality in ECG compared to baseline was based on investigator's discretion. | Week 13 of Part B |
| Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings | 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 abnormal change in any laboratory parameter compared to baseline were reported. | Part B: Day 1 up to Week 13 |
| Part A and B: Number of Participants With Positive Skin Sensitivity Reaction | The skin sensitivity reaction was assessed only at the skin sensitivity reaction testing sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. The number of participants that experienced any positive skin sensitivity reactions were reported. | From Day 21 of Part A up to Week 2 of Part B |
| St Louis |
| Missouri |
| 63141 |
| United States |
| NOT COMPLETED |
|
| BG001 | Cohort 2: EXC 001 and Placebo | In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. |
| BG002 | Cohort 3: EXC 001 and Placebo | In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10. |
| OG001 | Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo | Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10. |
| OG002 | Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo | Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11. |
| OG003 | Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo | Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11. |
| OG004 | Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo | Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10. |
| OG005 | Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo | Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10. |
|
|
| Secondary | Part B: Physician Observer Global Assessment Scar Score | Physician observer global assessment of scar score was done using a valid published 10-point rating scale. Physicians rated severity of each scar on a scale of 1 = normal skin to 10 = worst scar imaginable. Each scar was given a single score and the differences in scores between the matched pairs of scars were calculated. There were 4 differences within each dose level that were averaged to create a single score for each participant at each dose level. The score was defined as the within participant average difference between EXC 001 and Placebo. | Completer population included all participants who missed not more than 1 dose of study drug, had the Week 13 assessment and non-missing data for VAS scar assessment score for at least one dose level. | Posted | Mean | Standard Deviation | units on a scale | Week 13 of Part B |
|
|
|
| Secondary | Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and weight. Number of participants with clinically significant change in any vital sign parameter compared to Baseline were reported. Criteria for clinically significant change in any vital sign parameter compared to baseline was based on investigator's discretion. | Safety population included participants who completed Part A Day 1 visit of and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Part B: Day 1 up to Week 14 |
|
|
|
| Secondary | Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings | Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Criteria for clinically significant findings in physical examination was based on investigator's discretion. | Safety population included participants who completed Part A Day 1 visit of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Part B: Day 1 up to Week 14 |
|
|
|
| Secondary | Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings | Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's correction (QTc), heart rate (HR). A standard, single 12-lead ECG was taken and results was classified as normal, having a clinically insignificant abnormality, or having a clinically significant abnormality. Number of participants with clinically significant abnormality in ECG compared to baseline were reported. Criteria for clinically significant abnormality in ECG compared to baseline was based on investigator's discretion. | Safety population included participants who completed Part A Day 1 visit of and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 13 of Part B |
|
|
|
| Secondary | Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings | 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 abnormal change in any laboratory parameter compared to baseline were reported. | Safety population included participants who completed Part A Day 1 visit and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Part B: Day 1 up to Week 13 |
|
|
|
| Secondary | Part A and B: Number of Participants With Positive Skin Sensitivity Reaction | The skin sensitivity reaction was assessed only at the skin sensitivity reaction testing sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. The number of participants that experienced any positive skin sensitivity reactions were reported. | Safety population included participants who completed Part A Day 1 visit and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Day 21 of Part A up to Week 2 of Part B |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Part A: Cohort 2: EXC 001 | Participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. | 0 | 10 | 2 | 10 |
| EG002 | Part A: Cohort 3: EXC 001 | Participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection 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 surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. | 0 | 10 | 1 | 10 |
| EG003 | Part B: Cohort 1: EXC 001 and Placebo | Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. | 0 | 9 | 9 | 9 |
| EG004 | Part B: Cohort 2: EXC 001 and Placebo | Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. | 0 | 10 | 8 | 10 |
| EG005 | Part B: Cohort 3: EXC 001 and Placebo | Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14. | 0 | 10 | 8 | 10 |
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Incision site oedema | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
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.