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
Overview
- Phase
- Phase 2
- Intervention
- PF-06473871
- Conditions
- Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
- Sponsor
- Pfizer
- Enrollment
- 10
- Locations
- 5
- Primary Endpoint
- Part B: Number of Participants With Clinical Laboratory Abnormalities
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects previously randomized to Pfizer clinical study B
- •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of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.
Arms & Interventions
Group 1
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
Intervention: PF-06473871
Group 2
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
Intervention: PF-06473871
Outcomes
Primary Outcomes
Part B: Number of Participants With Clinical Laboratory Abnormalities
Time Frame: 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.
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Time Frame: 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
Time Frame: 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 Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Time Frame: 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.
Secondary Outcomes
- Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit(52 weeks after initial scar revision surgery in study B5301001)
- 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-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)