A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
- Conditions
- Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
- Interventions
- Registration Number
- NCT02205476
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 PF-06473871 The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses). Group 2 PF-06473871 The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
- Primary Outcome Measures
Name Time Method 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.
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 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.
- Secondary Outcome Measures
Name Time Method 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).
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.
Trial Locations
- Locations (5)
Primeter outpatient surgery center
🇺🇸Atlanta, Georgia, United States
Body Aesthetic Research Center
🇺🇸Saint Louis, Missouri, United States
Kavali Plastic Surgery and Skin Renewal Center
🇺🇸Atlanta, Georgia, United States
Bayside Ambulatory Center
🇺🇸Miami, Florida, United States
Stephan Baker MD PA
🇺🇸Coral Gables, Florida, United States