A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

A Long-term Efficacy Assessment Following Initial Scar Revision Surgery And Phase 2 Open-label Study To Evaluate Safety Of Re-treatment With Pf-06473871

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205476

Enrollment

Registered

2014-07-31

Start date

2014-12-31

Completion date

2015-01-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery

Keywords

Phase 2, open-label, safety, hypertrophic scar revision surgery

Brief summary

Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871.

Interventions

DRUGPF-06473871

Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 57 Years

Healthy volunteers

Inclusion criteria

* Subjects previously randomized to Pfizer clinical study B5301001. * Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation and local anesthesia.

Exclusion criteria

* Pregnant female subject; breastfeeding female subjects; male subjects with partners currently pregnant. * Any previous history of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Design outcomes

Primary

Measure	Time frame	Description
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)	Part B: Baseline up to Week 15	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.
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit	52 weeks after initial scar revision surgery in study B5301001	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).
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities	Part B: Baseline up to Week 15	Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.
Part B: Number of Participants With Clinical Laboratory Abnormalities	Part B: Baseline up to Week 15	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.

Secondary

Measure	Time frame	Description
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit	52 weeks after initial scar revision surgery in study B5301001	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).
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit	52 weeks after initial scar revision surgery in study B5301001	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.
Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit	52 weeks after initial scar revision surgery in study B5301001	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).

Other

Measure	Time frame	Description
Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit	52 weeks after initial scar revision surgery in study B5301001	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.

Countries

United States

Participant flow

Recruitment details

Participants who received the treatment in previous study B5301001 (NCT01730339), were enrolled in this study.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	7
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.	3
Total	10

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Study termination by Sponsor	7	3

Baseline characteristics

Characteristic	Group 1: PF--06473871/Placebo (4* 5 mg/cm)	Group 2: PF--06473871/Placebo (3* 5 mg/cm)	Total
Age, Continuous	40.7 years STANDARD_DEVIATION 6.8	39.0 years STANDARD_DEVIATION 15.13	40.2 years STANDARD_DEVIATION 9.08
Sex: Female, Male Female	7 Participants	3 Participants	10 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Part B: Number of Participants With Clinical Laboratory Abnormalities

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.

Time frame: Part B: Baseline up to Week 15

Population: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.

Primary

Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities

Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.

Time frame: Part B: Baseline up to Week 15

Population: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.

Primary

Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

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.

Time frame: Part B: Baseline up to Week 15

Population: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.

Primary

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit

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).