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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery Drug: PF-06473871 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Group 1
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
Drug: PF-06473871
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).
Drug: PF-06473871
Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. 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).

  2. 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.

  3. 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).


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02205476    
Other Study ID Numbers: B5301012
2014-002703-17 ( EudraCT Number )
First Posted: July 31, 2014    Key Record Dates
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016
Last Verified: December 2015
Keywords provided by Pfizer:
Phase 2
open-label
safety
hypertrophic scar revision surgery
Additional relevant MeSH terms:
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Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical