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

December 21, 2015 updated by: Pfizer

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Stephan Baker MD PA
      • Miami, Florida, United States, 33133
        • Bayside Ambulatory Center
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Kavali Plastic Surgery and Skin Renewal Center
      • Atlanta, Georgia, United States, 30328
        • Primeter outpatient surgery center
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Body Aesthetic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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 4 administration of PF-06473871.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
52 weeks after initial scar revision surgery in study B5301001
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: Baseline up to Week 15
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: Baseline up to Week 15
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.
Part B: Baseline up to Week 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
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.
52 weeks after initial scar revision surgery in study B5301001
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).
52 weeks after initial scar revision surgery in study B5301001

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
52 weeks after initial scar revision surgery in study B5301001

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B5301012
  • 2014-002703-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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