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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • 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

    Original Primary Outcome:

    • Physician scar assessment using the complete Patient and Observer Scar Assessment Scale (POSAS) at Part A visit. [ Time Frame: 1-8 weeks prior to screening ]
    • Physical examination including vital signs at Part B [ Time Frame: Screening, Week 0, Week 15 ]
    • Evaluation of clinical laboratory tests at Part B [ Time Frame: Screening, Week 0, Week 15 ]
    • Evaluation of adverse events at Part B [ Time Frame: Screening, week 0, Week 15 ]


    Current Secondary Outcome:

    • 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).


    Original Secondary Outcome:

    • Patient Global Assess: The patient overall opinion of the POSAS at Part A visit [ Time Frame: 1-8 week prior to screening ]
    • Patient reported scar evaluation questionnaire (PR-SEQ) at Part A visit [ Time Frame: 1-8 week prior to screening ]
    • Physician & Subject Photoguide Scar Assessment at Part A visit [ Time Frame: 1-8 week prior to screening ]
    • Volumetric & colorimetric scar assessment at Part A visit [ Time Frame: 1-8 week prior to screening ]


    Information By: Pfizer

    Dates:
    Date Received: July 29, 2014
    Date Started: December 2014
    Date Completion:
    Last Updated: December 21, 2015
    Last Verified: December 2015