A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
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|ClinicalTrials.gov Identifier: NCT02205476|
Recruitment Status : Terminated (B5301001 study did not meet its predefined efficacy endpoints, the long term follow up study B5301012 was terminated in 1/6/2015. No safety concerns identified.)
First Posted : July 31, 2014
Results First Posted : January 28, 2016
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery||Drug: PF-06473871||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Group 1
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.
Experimental: Group 2
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.
- 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 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.
- 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.
- Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
- Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205476
|United States, Florida|
|Stephan Baker MD PA|
|Coral Gables, Florida, United States, 33146|
|Bayside Ambulatory Center|
|Miami, Florida, United States, 33133|
|United States, Georgia|
|Kavali Plastic Surgery and Skin Renewal Center|
|Atlanta, Georgia, United States, 30328|
|Primeter outpatient surgery center|
|Atlanta, Georgia, United States, 30328|
|United States, Missouri|
|Body Aesthetic Research Center|
|Saint Louis, Missouri, United States, 63141|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|