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| ID | Type | Description | Link |
|---|---|---|---|
| B5301011 | Other Identifier | Alias Study Number |
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This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. 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 | Multiple intradermal injections of EXC 001 and placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Expert Panel Scar Assessment Score at Week 12 | 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. | Part B: Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Expert Panel Scar Assessment Score at Week 8 and 24 | 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. | Part B: Week 8 and 24 |
| Physician Observer Scar Assessment Score at Week 12 and 24 |
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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 |
|---|---|---|---|---|---|---|
| Scripps medical | La Jolla | California | 92037 | United States | ||
| Northwestern University,Division of Plastic Surgery |
Not provided
| 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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Skin Testing |
|
| |||||||||||||||||||||
| Part B: Scar Revision |
|
Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | All participants who were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Expert Panel Scar Assessment Score at Week 12 | 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. | 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. | Posted | Mean | Standard Deviation | millimeter | Part B: Week 12 |
|
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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 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.
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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 | EXC 001 During Part A | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Multiple intradermal injections of EXC 001 and placebo |
|
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. |
| Part B: Week 12 and 24 |
| Participant Observer Scar Assessment Score at Week 12 and 24 | Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range =1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range =1 (no, same as normal skin) to 10 (yes, very different), 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. | Part B: Week 12 and 24 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | 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) |
| Number of Participants With Abnormal 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. Abnormal physical examination findings was based on investigator's discretion. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12 |
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12 |
| Number of Participants With Clinically Significant Findings in Laboratory Examinations | 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. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 |
| Number of Participants With Clinically Significant Findings in Vital Signs | 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. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 |
| Number of Participants With Positive Skin Sensitivity Reaction | 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. | Part A: Day 1, Part B: Week 2 up to Week 24 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Body Aesthetic Plastic Surgery | St Louis | Missouri | 63141 | United States |
| Jewell Plastic Surgery Center | Eugene | Oregon | 97401 | United States |
| Connall Consmetic Surgery | Tualatin | Oregon | 97062 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Expert Panel Scar Assessment Score at Week 8 and 24 | 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. | 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. | Posted | Mean | Standard Deviation | millimeter | Part B: Week 8 and 24 |
|
|
|
|
| Secondary | Physician Observer Scar Assessment Score at Week 12 and 24 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Part B: Week 12 and 24 |
|
|
|
|
| Secondary | Participant Observer Scar Assessment Score at Week 12 and 24 | Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range =1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range =1 (no, same as normal skin) to 10 (yes, very different), 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Part B: Week 12 and 24 |
|
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Secondary | Number of Participants With Abnormal 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. Abnormal physical examination findings was based on investigator's discretion. | 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. | Posted | Count of Participants | Participants | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion. | 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. | Posted | Count of Participants | Participants | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Findings in Laboratory Examinations | 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. | 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. | Posted | Count of Participants | Participants | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Findings in Vital Signs | 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. | 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. | Posted | Count of Participants | Participants | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 |
|
|
|
| Secondary | Number of Participants With Positive Skin Sensitivity Reaction | 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. | Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Part A: Day 1, Part B: Week 2 up to Week 24 |
|
|
|
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | EXC 001 + Placebo During Part B, Active Dosing Phase | 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. | 1 | 22 | 16 | 22 |
| EG002 | 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. | 0 | 22 | 3 | 22 |
| Bronchitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Incision site oedema | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Itching scar | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Keloid scar | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Application site scab | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site exfoliation | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | 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.
| Week 24 |
|
|
| t-test, 2 sided |
| <0.001 |
| Mean Difference (Final Values) |
| -26.0 |
| 2-Sided |
| 95 |
| -34.3 |
| -17.7 |
| Superiority |
| Week 12: Thickness |
|
| Week 12: Relief |
|
| Week 12: Pliability |
|
| Week 12: Surface Area |
|
| Week 12: Overall Opinion |
|
| Week 12: Composite Score |
|
| Week 24: Vascularity |
|
| Week 24: Pigmentation |
|
| Week 24: Thickness |
|
| Week 24: Relief |
|
| Week 24: Pliability |
|
| Week 24: Surface Area |
|
| Week 24: Overall Opinion |
|
| Week 24: Composite Score |
|
| t-test, 2 sided |
| 0.003 |
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -1.9 |
| -0.4 |
| Superiority |
| Week 12, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -1.7 | 2-Sided | 95 | -2.5 | -0.8 | Superiority |
| Week 12, Relief: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -2.7 | -1.0 | Superiority |
| Week 12, Pliability: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.012 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -1.9 | -0.3 | Superiority |
| Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.003 | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -2.4 | -0.5 | Superiority |
| Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -2.6 | -1.1 | Superiority |
| Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -8.4 | 2-Sided | 95 | -12.7 | -4.0 | Superiority |
| Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -2.3 | 2-Sided | 95 | -3.2 | -1.4 | Superiority |
| Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -2.9 | -0.9 | Superiority |
| Week 24, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.001 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -2.8 | -0.8 | Superiority |
| Week 24, Relief: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -2.4 | 2-Sided | 95 | -3.6 | -1.3 | Superiority |
| Week 24, Pliability: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.005 | Mean Difference (Final Values) | -2.0 | 2-Sided | 95 | -3.2 | -0.7 | Superiority |
| Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -2.2 | 2-Sided | 95 | -3.1 | -1.2 | Superiority |
| Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -2.4 | 2-Sided | 95 | -3.3 | -1.5 | Superiority |
| Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -12.6 | 2-Sided | 95 | -17.7 | -7.4 | Superiority |
| Week 12: Color |
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| Week 12: Stiffness |
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| Week 12: Thickness |
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| Week 12: Irregular |
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| Week 12: Overall Opinion |
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| Week 12: Composite Score |
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| Week 12: Scar Appearance Composite Score |
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| Week 24: Pain |
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| Week 24: Itching |
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| Week 24: Color |
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| Week 24: Stiffness |
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| Week 24: Thickness |
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| Week 24: Irregular |
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| Week 24: Overall Opinion |
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| Week 24: Composite Score |
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| Week 24: Scar Appearance Composite Score |
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| t-test, 2 sided |
| 0.413 |
| Mean Difference (Final Values) |
| -0.3 |
| 2-Sided |
| 95 |
| -1.2 |
| 0.5 |
| Superiority |
| Week 12, Color: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.401 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.6 | 0.7 | Superiority |
| Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.083 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -2.4 | 0.2 | Superiority |
| Week 12, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.052 | Mean Difference (Final Values) | -1.1 | 2-Sided | 95 | -2.3 | 0.0 | Superiority |
| Week 12, Irregular: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.036 | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -2.3 | -0.1 | Superiority |
| Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.045 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.1 | -0.0 | Superiority |
| Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.054 | Mean Difference (Final Values) | -4.9 | 2-Sided | 95 | -9.9 | 0.1 | Superiority |
| Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.065 | Mean Difference (Final Values) | -4.0 | 2-Sided | 95 | -8.2 | 0.3 | Superiority |
| Week 24, Pain: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.079 | Mean Difference (Final Values) | -1.0 | 2-Sided | 95 | -2.0 | 0.1 | Superiority |
| Week 24, Itching: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.158 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1.5 | 0.3 | Superiority |
| Week 24, Color: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.010 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -3.0 | -0.5 | Superiority |
| Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.003 | Mean Difference (Final Values) | -2.1 | 2-Sided | 95 | -3.5 | -0.8 | Superiority |
| Week 24, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.005 | Mean Difference (Final Values) | -2.4 | 2-Sided | 95 | -4.0 | -0.8 | Superiority |
| Week 24, Irregular: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.032 | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -3.5 | -0.2 | Superiority |
| Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.003 | Mean Difference (Final Values) | -2.3 | 2-Sided | 95 | -3.8 | -0.9 | Superiority |
| Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.006 | Mean Difference (Final Values) | -9.8 | 2-Sided | 95 | -16.4 | -3.1 | Superiority |
| Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.004 | Mean Difference (Final Values) | -8.2 | 2-Sided | 95 | -13.4 | -3.0 | Superiority |
| Title | Measurements |
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| Week 12 of Part B |
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