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| ID | Type | Description | Link |
|---|---|---|---|
| B5301003 | Other Identifier | Alias Study Number |
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The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXC 001 (currently called PF-06473871) | Drug | Single dose administered by injection at four different times |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2 to Week 24 |
| 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 appeared to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. In this outcome measure number of participants with any positive skin sensitivity reaction were reported. | Day 1 up to Week 24 |
| Number of Participants With Clinically Significant Findings in Laboratory Examinations | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion. | Day 1 up to Week 24 |
| Number of Participants With Clinically Significant Change in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score | Physician assessment of scar was done using a valid published 10-point rating scale. Assessment included following sub scores: vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar, on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the sub scores except the overall opinion score and range from 6 (best score) to 60 (worst score). |
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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 |
|---|---|---|---|---|---|---|
| Altus Research | Lake Worth | Florida | 33461 | United States | ||
| Northwestern University,Division of 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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Participants who participated in any of the previous studies (EXC 001-202 [NCT01037985], EXC 001-203 [NCT01037413] and EXC 001-204 [NCT01346969]), had scars at a minimum of 1 year after surgery in previous study which qualified for scar revision and chose scar revision treatment with EXC 001 (PF-06473871) were eligible for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | EXC 001 (PF-06473871) | Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 milligram per centimeter (mg/cm) at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 centimeter (cm). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who completed the scar revision surgery (Day 1 visit).
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| ID | Title | Description |
|---|---|---|
| BG000 | EXC 001 (PF-06473871) | Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 mg/cm at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 cm. |
| 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 | 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 all participants who completed the scar revision surgery (Day 1 visit). | Posted | Count of Participants | Participants | Week 2 to Week 24 |
|
Week 2 to Week 24
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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 (PF-06473871) | Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 mg/cm at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 cm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 12.1 | 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 |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Day 1 up to Week 24 |
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities | Following parameters were analyzed: heart rate, PR interval, QT interval, QRS interval and QT interval corrected using Fridericia's formula (QTcF). Clinically significant findings in ECG were based on investigator's discretion. | Day 1 up to Week 24 |
| Number of Participants With Abnormalities in Physical Examinations | Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion. | Day 1 up to Week 24 |
| Week 24 |
| Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score | Participants rated pain, itching, color, stiffness, thickness, irregularity and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score is the sum of all sub scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score is the sum of all sub scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). | Week 24 |
| Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category | Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants. | Week 24 |
| Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category | Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants. | Week 24 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Jewell Plastic Surgery Center | Eugene | Oregon | 97401 | United States |
| Connall Consmetic Surgery | Tualatin | Oregon | 97062 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 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 appeared to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. In this outcome measure number of participants with any positive skin sensitivity reaction were reported. | Safety population included all participants who completed the scar revision surgery (Day 1 visit). | Posted | Count of Participants | Participants | Day 1 up to Week 24 |
|
|
|
| Primary | Number of Participants With Clinically Significant Findings in Laboratory Examinations | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion. | Safety population included all participants who completed the scar revision surgery (Day 1 visit). | Posted | Count of Participants | Participants | Day 1 up to Week 24 |
|
|
|
| Primary | Number of Participants With Clinically Significant Change in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion. | Safety population included all participants who completed the scar revision surgery (Day 1 visit). | Posted | Count of Participants | Participants | Day 1 up to Week 24 |
|
|
|
| Primary | Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities | Following parameters were analyzed: heart rate, PR interval, QT interval, QRS interval and QT interval corrected using Fridericia's formula (QTcF). Clinically significant findings in ECG were based on investigator's discretion. | Safety population included all participants who completed the scar revision surgery (Day 1 visit). | Posted | Count of Participants | Participants | Day 1 up to Week 24 |
|
|
|
| Primary | Number of Participants With Abnormalities in Physical Examinations | Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion. | Safety population included all participants who completed the scar revision surgery (Day 1 visit). | Posted | Count of Participants | Participants | Day 1 up to Week 24 |
|
|
|
| Secondary | Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score | Physician assessment of scar was done using a valid published 10-point rating scale. Assessment included following sub scores: vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar, on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the sub scores except the overall opinion score and range from 6 (best score) to 60 (worst score). | Analysis population included all participants who completed Week 24 efficacy assessments. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| Secondary | Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score | Participants rated pain, itching, color, stiffness, thickness, irregularity and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score is the sum of all sub scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score is the sum of all sub scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). | Analysis population included all participants who completed Week 24 efficacy assessments. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| Secondary | Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category | Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants. | Analysis population included all participants who completed Week 24 efficacy assessments. Here, "type of unit analyzed" signifies number of scars evaluable. | Posted | Number | scars | Week 24 | scars | scars |
|
|
|
| Secondary | Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category | Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants. | Analysis population included all participants who completed Week 24 efficacy assessments. Here, "type of unit analyzed" signifies number of scars evaluable. | Posted | Number | scars | Week 24 | scars | scars |
|
|
|
| 0 |
| 14 |
| 8 |
| 14 |
| Fungal Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Headache | Nervous system 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.
| Title | Measurements |
|---|---|
|
| Thickness |
|
| Relief |
|
| Pliability |
|
| Surface area |
|
| Composite Score |
|
| Title | Measurements |
|---|---|
|
| Color |
|
| Stiffness |
|
| Thickness |
|
| Irregular |
|
| Composite Score |
|
| Scar Appearance composite Score |
|
| Individual Scar: Mild |
|
|
| Individual Scar: Moderate |
|
|
| Individual Scar: Severe |
|
|
| Individual Scar: Very Severe |
|
|
| Most Severe Scar: Minimal |
|
|
| Most Severe Scar: Mild |
|
|
| Most Severe Scar: Moderate |
|
|
| Most Severe Scar: Severe |
|
|
| Most Severe Scar: Very Severe |
|
|
| Individual Scar: Mild |
|
|
| Individual Scar: Moderate |
|
|
| Individual Scar: Severe |
|
|
| Individual Scar: Very Severe |
|
|
| Most Severe Scar: Minimal |
|
|
| Most Severe Scar: Mild |
|
|
| Most Severe Scar: Moderate |
|
|
| Most Severe Scar: Severe |
|
|
| Most Severe Scar: Very Severe |
|
|