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| ID | Type | Description | Link |
|---|---|---|---|
| B5301010 | 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 | Multiple intradermal injections of EXC 001 and placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Expert Panel Scar Assessment Score at Week 12: Part B | Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant were presented and evaluated 3 times by an expert panel. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Expert Panel Scar Assessment Score at Week 24: Part B | Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant was presented and evaluated 3 times by an expert panel. | Week 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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Participants who had chosen and qualified (sufficient excess abdominal tissue) for a standard elective abdominoplasty 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 (abdominoplasty surgery) of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | EXC 001 (PF-0647387) During Part A | In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21. 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 surgery. The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B. |
| FG001 | EXC 001 (PF-0647387) + Placebo During Part B | Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty 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 abdominoplasty incision on one side of the midline and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Skin Testing (50 Days) |
|
| |||||||||||||||||||||
| Part B:Abdominoplasty Surgery (24 Weeks) |
|
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 | 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: Part B | Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant were presented and evaluated 3 times by an expert panel. | 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 | 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 separately for EXC 001 and placebo.
Not provided
| 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 (PF-0647387) During Part A | In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 mg on Day 1 and 21. 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 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 in Part B. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 Scar Assessment Score at Week 12 and 24: Part B |
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score). |
| Week 12 and 24 |
| Participants Observer Scar Assessment Score at Week 12 and 24: Part B | Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). | 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. | Day 1 of Part A up to Week 24 of Part B |
| Number of Participants With Abnormal Physical Examinations Findings: Part A and Part B | 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 examinations findings was based on investigator's discretion. | Day 1 of Part A up to Week 12 of Part B |
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG): Part A and Part B | Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion. | Day 1 of Part A up to Week 12 of Part B |
| Number of Participants With Clinically Significant Findings in Laboratory Examinations: Part A and Part B | 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. | Day 1 of Part A up to Week 12 of Part B |
| Number of Participants With Clinically Significant Findings in Vital Signs and Weight: Part A and Part B | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Number of participants with clinically significant change in any vital sign parameter and weight compared to baseline were reported. Clinical significance was based on investigator's discretion. | Day 1 of Part A up to Week 12 of Part B |
| Number of Participants With Positive Skin Sensitivity Reaction: Part A and Part B | 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. | Day 21 of Part A up to Day 14 of Part B |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Barnes Jewish West County Hospital | St Louis | Missouri | 63141 | 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 abdominoplasty 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 abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed. |
|
|
|
| Secondary | Expert Panel Scar Assessment Score at Week 24: Part B | Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant was presented and evaluated 3 times by an expert panel. | 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 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimeter | Week 24 |
|
|
|
|
| Secondary | Physician Observer Scar Assessment Score at Week 12 and 24: Part B | Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score). | 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 'n' signifies those participants who were evaluable at specified time-point. | Posted | Mean | Standard Deviation | units on a scale | Week 12 and 24 |
|
|
|
|
| Secondary | Participants Observer Scar Assessment Score at Week 12 and 24: Part B | Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). | 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 'n' signifies those participants who were evaluable at specified time-point. | Posted | Mean | Standard Deviation | units on a scale | 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 | Day 1 of Part A up to Week 24 of Part B |
|
|
|
| Secondary | Number of Participants With Abnormal Physical Examinations Findings: Part A and Part B | 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 examinations 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. | Posted | Count of Participants | Participants | Day 1 of Part A up to Week 12 of Part B |
|
|
|
| Secondary | Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG): Part A and Part B | 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. | Posted | Count of Participants | Participants | Day 1 of Part A up to Week 12 of Part B |
|
|
|
| Secondary | Number of Participants With Clinically Significant Findings in Laboratory Examinations: Part A and Part B | 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. | Posted | Count of Participants | Participants | Day 1 of Part A up to Week 12 of Part B |
|
|
|
| Secondary | Number of Participants With Clinically Significant Findings in Vital Signs and Weight: Part A and Part B | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Number of participants with clinically significant change in any vital sign parameter and weight compared to baseline 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. | Posted | Count of Participants | Participants | Day 1 of Part A up to Week 12 of Part B |
|
|
|
| Secondary | Number of Participants With Positive Skin Sensitivity Reaction: Part A and Part B | 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 | Day 21 of Part A up to Day 14 of Part B |
|
|
|
| 0 |
| 41 |
| 7 |
| 41 |
| EG001 | Active Dosing Phase During Part B | Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty 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 abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed. Active dosing phase was from Week 2 to Week 13. | 0 | 33 | 18 | 33 |
| EG002 | Post Dosing Phase During Part B | 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 | 32 | 3 | 32 |
| Sinusitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Infusion site rash | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal 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 12: Pigmentation |
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| Week 12: Thickness |
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| Week 12: Relief |
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| Week 12: Pliability |
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| Week 12: Surface Area |
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| Week 12: Overall Opinion |
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| Week 12: Composite Score |
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| Week 24: Vascularity |
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| Week 24: Pigmentation |
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| Week 24: Thickness |
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| Week 24: Relief |
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| Week 24: Pliability |
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| Week 24: Surface Area |
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| Week 24: Overall Opinion |
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| Week 24: Composite Score |
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|
| t-test, 2 sided |
| 0.067 |
| Mean Difference (Final Values) |
| -0.5 |
| 2-Sided |
| 95 |
| -1.1 |
| 0.0 |
| Superiority |
| Week 12, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -1.4 | 2-Sided | 95 | -2.1 | -0.7 | Superiority |
| Week 12, Relief: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.002 | Median Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.4 | -0.4 | Superiority |
| Week 12, Pliability: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.007 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.3 | -0.2 | Superiority |
| Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.214 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -1.1 | 0.3 | Superiority |
| Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.003 | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.5 | -0.3 | Superiority |
| Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | <0.001 | Mean Difference (Final Values) | -5.0 | 2-Sided | 95 | -7.8 | -2.2 | Superiority |
| Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.673 | Mean Difference (Net) | 0.1 | 2-Sided | 95 | -0.5 | 0.7 | Superiority |
| Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.276 | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | -0.3 | 1.1 | Superiority |
| Week 24, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.670 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.7 | 0.5 | Superiority |
| Week 24, Relief: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 1.000 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.5 | 0.5 | Superiority |
| Week 24, Pliability: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.909 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.5 | 0.6 | Superiority |
| Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.852 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.6 | 0.8 | Superiority |
| Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.906 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.5 | 0.6 | Superiority |
| Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.768 | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -2.8 | 3.8 | Superiority |
| Week 12: Itching |
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| 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 |
|
|
| t-test, 2 sided |
| 1.000 |
| Mean Difference (Final Values) |
| 0.0 |
| 2-Sided |
| 95 |
| -0.4 |
| 0.4 |
| Superiority |
| Week 12, Color: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.072 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.4 | 0.1 | Superiority |
| Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.851 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.7 | 0.6 | Superiority |
| Week 12, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.184 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.2 | 0.2 | Superiority |
| Week 12, Irregular: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.059 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.3 | 0.0 | Superiority |
| Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.040 | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.5 | -0.0 | Superiority |
| Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.120 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -4.1 | 0.5 | Superiority |
| Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.094 | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -4.0 | 0.3 | Superiority |
| Week 24, Pain: Comparison within the participant between EXC 001 and placebo. | t-test, 1 sided | 0.243 | Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -0.2 | 0.6 | Superiority |
| Week 24, Itching: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.339 | Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -0.2 | 0.6 | Superiority |
| Week 24, Color: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.250 | Mean Difference (Final Values) | 0.5 | 2-Sided | 95 | -0.3 | 1.2 | Superiority |
| Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.164 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.3 | 0.2 | Superiority |
| Week 24, Thickness: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 1.000 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.8 | 0.8 | Superiority |
| Week 24, Irregular: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.928 | Mean Difference (Final Values) | -0.0 | 2-Sided | 95 | -0.8 | 0.7 | Superiority |
| Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.865 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.8 | 0.7 | Superiority |
| Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.804 | Mean Difference (Final Values) | 0.3 | 2-Sided | 95 | -2.3 | 3.0 | Superiority |
| Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo. | t-test, 2 sided | 0.937 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -2.6 | 2.4 | Superiority |