Trial Outcomes & Findings for A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study (NCT NCT02205476)
NCT ID: NCT02205476
Last Updated: 2016-01-28
Results Overview
Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (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).
TERMINATED
PHASE2
10 participants
52 weeks after initial scar revision surgery in study B5301001
2016-01-28
Participant Flow
Participants who received the treatment in previous study B5301001 (NCT01730339), were enrolled in this study.
Participants who completed part A of the study had the option to obtain scar revision surgery with PF-06473871 in part B of the study. No participant entered into part B due to premature termination of the study.
Participant milestones
| Measure |
Group 1: PF--06473871/Placebo (4* 5 mg/cm)
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
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|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Group 1: PF--06473871/Placebo (4* 5 mg/cm)
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
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|---|---|---|
|
Overall Study
Study termination by Sponsor
|
7
|
3
|
Baseline Characteristics
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
Baseline characteristics by cohort
| Measure |
Group 1: PF--06473871/Placebo (4* 5 mg/cm)
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF--06473871/Placebo (3* 5 mg/cm)
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 6.80 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 15.13 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeks after initial scar revision surgery in study B5301001Population: Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (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).
Outcome measures
| Measure |
Group 1: PF--06473871: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 1: Placebo: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: Placebo: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
|---|---|---|---|---|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Vascularity
|
2.71 units on scale
Standard Deviation 1.496
|
2.71 units on scale
Standard Deviation 1.113
|
1.33 units on scale
Standard Deviation 0.577
|
2.00 units on scale
Standard Deviation 1.000
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Pigmentation
|
3.79 units on scale
Standard Deviation 2.307
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5.00 units on scale
Standard Deviation 2.517
|
2.00 units on scale
Standard Deviation 1.000
|
3.00 units on scale
Standard Deviation 2.000
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Thickness
|
3.86 units on scale
Standard Deviation 2.478
|
4.64 units on scale
Standard Deviation 2.286
|
2.00 units on scale
Standard Deviation 1.000
|
3.00 units on scale
Standard Deviation 2.000
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Relief
|
4.14 units on scale
Standard Deviation 2.795
|
4.36 units on scale
Standard Deviation 2.358
|
2.00 units on scale
Standard Deviation 1.000
|
3.67 units on scale
Standard Deviation 3.055
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Pliability
|
3.50 units on scale
Standard Deviation 2.693
|
3.93 units on scale
Standard Deviation 2.805
|
1.67 units on scale
Standard Deviation 0.577
|
3.67 units on scale
Standard Deviation 3.055
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Surface Area
|
4.86 units on scale
Standard Deviation 2.193
|
4.57 units on scale
Standard Deviation 2.573
|
2.33 units on scale
Standard Deviation 0.577
|
3.33 units on scale
Standard Deviation 2.517
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Overall opinion
|
4.29 units on scale
Standard Deviation 2.628
|
4.64 units on scale
Standard Deviation 2.561
|
2.00 units on scale
Standard Deviation 1.000
|
3.00 units on scale
Standard Deviation 2.000
|
PRIMARY outcome
Timeframe: Part B: Baseline up to Week 15Population: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Part B: Baseline up to Week 15Population: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Part B: Baseline up to Week 15Population: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeks after initial scar revision surgery in study B5301001Population: Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
Outcome measures
| Measure |
Group 1: PF--06473871: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 1: Placebo: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: Placebo: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
|---|---|---|---|---|
|
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
|
7.07 units on scale
Standard Deviation 2.281
|
6.57 units on scale
Standard Deviation 3.552
|
3.00 units on scale
Standard Deviation 1.732
|
4.00 units on scale
Standard Deviation 2.646
|
SECONDARY outcome
Timeframe: 52 weeks after initial scar revision surgery in study B5301001Population: Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing \[14 attributes\]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.
Outcome measures
| Measure |
Group 1: PF--06473871: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 1: Placebo: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: Placebo: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
|---|---|---|---|---|
|
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit
Appearance
|
46.79 units on scale
Standard Deviation 28.965
|
49.29 units on scale
Standard Deviation 30.745
|
33.33 units on scale
Standard Deviation 12.583
|
48.33 units on scale
Standard Deviation 41.633
|
|
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit
Symptoms
|
23.21 units on scale
Standard Deviation 24.516
|
9.52 units on scale
Standard Deviation 16.962
|
0.00 units on scale
Standard Deviation 0.000
|
0.00 units on scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: 52 weeks after initial scar revision surgery in study B5301001Population: Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).
Outcome measures
| Measure |
Group 1: PF--06473871: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
|
Group 1: Placebo: 4* 5 mg/cm
n=7 Participants
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
Group 2: Placebo: 3* 5 mg/cm
n=3 Participants
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
|
|---|---|---|---|---|
|
Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
Physician assessment
|
2.64 units on scale
Standard Deviation 1.600
|
3.00 units on scale
Standard Deviation 1.414
|
1.33 units on scale
Standard Deviation 0.577
|
2.33 units on scale
Standard Deviation 1.528
|
|
Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
Participant assessment
|
2.79 units on scale
Standard Deviation 1.577
|
3.14 units on scale
Standard Deviation 1.773
|
1.67 units on scale
Standard Deviation 0.577
|
2.67 units on scale
Standard Deviation 2.082
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 52 weeks after initial scar revision surgery in study B5301001Population: The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.
Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: PF--06473871/Placebo (4* 5 mg/cm)
Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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