Trial Outcomes & Findings for Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001 (NCT NCT01494922)
NCT ID: NCT01494922
Last Updated: 2021-08-13
Results Overview
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.
COMPLETED
PHASE2
14 participants
Day 1 up to Week 24
2021-08-13
Participant Flow
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.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
Baseline characteristics by cohort
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 7.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2 to Week 24Population: Safety population included all participants who completed the scar revision surgery (Day 1 visit).
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs and all non-SAEs that occurred during the study.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 24Population: Safety population included all participants who completed the scar revision surgery (Day 1 visit).
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Number of Participants With Positive Skin Sensitivity Reaction
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 24Population: Safety population included all participants who completed the scar revision surgery (Day 1 visit).
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Findings in Laboratory Examinations
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 24Population: Safety population included all participants who completed the scar revision surgery (Day 1 visit).
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Change in Vital Signs
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 24Population: Safety population included all participants who completed the scar revision surgery (Day 1 visit).
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 24Population: Safety population included all participants who completed the scar revision surgery (Day 1 visit).
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=14 Participants
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.
|
|---|---|
|
Number of Participants With Abnormalities in Physical Examinations
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who completed Week 24 efficacy assessments.
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).
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=13 Participants
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.
|
|---|---|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Overall opinion
|
4.63 units on a scale
Standard Deviation 2.033
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Vascularity
|
4.02 units on a scale
Standard Deviation 1.838
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Pigmentation
|
3.83 units on a scale
Standard Deviation 1.848
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Thickness
|
4.55 units on a scale
Standard Deviation 2.022
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Relief
|
4.06 units on a scale
Standard Deviation 2.112
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Pliability
|
3.97 units on a scale
Standard Deviation 1.932
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Surface area
|
4.71 units on a scale
Standard Deviation 1.534
|
|
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score
Composite Score
|
25.15 units on a scale
Standard Deviation 8.744
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who completed Week 24 efficacy assessments.
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).
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=13 Participants
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.
|
|---|---|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Overall opinion
|
6.21 units on a scale
Standard Deviation 2.660
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Pain
|
2.46 units on a scale
Standard Deviation 1.620
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Itching
|
2.03 units on a scale
Standard Deviation 1.234
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Color
|
6.72 units on a scale
Standard Deviation 2.323
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Stiffness
|
5.76 units on a scale
Standard Deviation 2.487
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Thickness
|
5.56 units on a scale
Standard Deviation 2.508
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Irregular
|
5.62 units on a scale
Standard Deviation 2.494
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Composite Score
|
28.15 units on a scale
Standard Deviation 10.457
|
|
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score
Scar Appearance composite Score
|
23.67 units on a scale
Standard Deviation 9.110
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who completed Week 24 efficacy assessments. Here, "type of unit analyzed" signifies number of scars evaluable.
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=28 scars
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.
|
|---|---|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Individual Scar: Minimal
|
5 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Individual Scar: Mild
|
12 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Individual Scar: Moderate
|
4 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Individual Scar: Severe
|
1 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Individual Scar: Very Severe
|
6 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Most Severe Scar: Minimal
|
2 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Most Severe Scar: Mild
|
4 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Most Severe Scar: Moderate
|
2 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Most Severe Scar: Severe
|
1 scars
|
|
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category
Most Severe Scar: Very Severe
|
4 scars
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who completed Week 24 efficacy assessments. Here, "type of unit analyzed" signifies number of scars evaluable.
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.
Outcome measures
| Measure |
EXC 001 (PF-06473871)
n=28 scars
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.
|
|---|---|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Individual Scar: Minimal
|
6 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Individual Scar: Mild
|
7 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Individual Scar: Moderate
|
6 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Individual Scar: Severe
|
3 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Individual Scar: Very Severe
|
6 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Most Severe Scar: Minimal
|
2 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Most Severe Scar: Mild
|
1 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Most Severe Scar: Moderate
|
4 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Most Severe Scar: Severe
|
1 scars
|
|
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category
Most Severe Scar: Very Severe
|
5 scars
|
Adverse Events
EXC 001 (PF-06473871)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EXC 001 (PF-06473871)
n=14 participants at risk
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.
|
|---|---|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Week 2 to Week 24
|
|
Infections and infestations
Fungal Infection
|
7.1%
1/14 • Week 2 to Week 24
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
7.1%
1/14 • Week 2 to Week 24
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.1%
1/14 • Week 2 to Week 24
|
|
General disorders
Injection site erythema
|
14.3%
2/14 • Week 2 to Week 24
|
|
General disorders
Injection site induration
|
7.1%
1/14 • Week 2 to Week 24
|
|
General disorders
Injection site pain
|
7.1%
1/14 • Week 2 to Week 24
|
|
General disorders
Injection site pruritus
|
7.1%
1/14 • Week 2 to Week 24
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.1%
1/14 • Week 2 to Week 24
|
|
Gastrointestinal disorders
Lip swelling
|
7.1%
1/14 • Week 2 to Week 24
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Week 2 to Week 24
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Week 2 to Week 24
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Week 2 to Week 24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Week 2 to Week 24
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Week 2 to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER