Hypertrophic Scars Resulting From Prior Breast Scar Revision SurgeryPhase 2NCT02205476

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

A Phase 2 study testing PF-06473871 in people with Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery, run by Pfizer at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 57 years
Conditions the study is for: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
What is being tested?: PF-06473871
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 5 sitesUnited States
Study dates: Dec 2014to Jan 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 57 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

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 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.

Conditions: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Being tested: PF-06473871
Keywords: Phase 2, open-label, safety, hypertrophic scar revision surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06473871Drug
Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.
PF-06473871Drug
Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.

Study groups in NCT02205476
Study group	Role	What they receive
Group 1	Experimental	The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses). Receives: Drug: PF-06473871
Group 2	Experimental	The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses). Receives: Drug: PF-06473871

What is being measured

The primary outcome is the main question the study is designed to answer.

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
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).
Measured: 52 weeks after initial scar revision surgery in study B5301001
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.
Measured: Part B: Baseline up to Week 15
Part B: Number of Participants With Clinical Laboratory Abnormalities
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.
Measured: Part B: Baseline up to Week 15
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
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.
Measured: Part B: Baseline up to Week 15

Secondary outcomes (3)

Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
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).
Measured: 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
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.
Measured: 52 weeks after initial scar revision surgery in study B5301001
Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
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).
Measured: 52 weeks after initial scar revision surgery in study B5301001

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Jan 2015

First posted31 Jul 2014 (estimated)
Study startDec 2014
Primary completionJan 2015
Study completionJan 2015

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypertrophic Scars Resulting From Prior Breast Scar Revision SurgeryStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02205476
Sponsor's protocol ID: B5301012
Other IDs: 2014-002703-17, 2014
Status last verified: Dec 2015
First submitted: 29 Jul 2014
Last updated: 28 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02205476
Acronym / sponsor ID: B5301012
Conditions: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Keywords: Phase 2, open-label, safety, hypertrophic scar revision surgery
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 10 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 31 Jul 2014 (estimated)
Results: Posted 28 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Drug: PF-06473871The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
Group 2	Experimental	Drug: PF-06473871The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).

Who may qualify

Ages: 18 to 57 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06473871Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.	Drug	Group 1
PF-06473871Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.	Drug	Group 2

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 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.

3 secondary outcomes

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-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
Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
Time frame: 52 weeks after initial scar revision surgery in study B5301001

Results and safety

Results posted to the registry on 28 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: PF--06473871/Placebo (4* 5 mg/cm)	7	0
Group 2: PF--06473871/Placebo (3* 5 mg/cm)	3	0

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. Mean (Standard Deviation). Unit: units on scale

Measure	Group 1: PF--06473871: 4* 5 mg/cm n = 7	Group 1: Placebo: 4* 5 mg/cm n = 7	Group 2: PF¬06473871: 3* 5 mg/cm n = 3	Group 2: Placebo: 3* 5 mg/cm n = 3
Vascularity	2.71 (1.496)	2.71 (1.113)	1.33 (0.577)	2.00 (1.000)
Pigmentation	3.79 (2.307)	5.00 (2.517)	2.00 (1.000)	3.00 (2.000)
Thickness	3.86 (2.478)	4.64 (2.286)	2.00 (1.000)	3.00 (2.000)
Relief	4.14 (2.795)	4.36 (2.358)	2.00 (1.000)	3.67 (3.055)
Pliability	3.50 (2.693)	3.93 (2.805)	1.67 (0.577)	3.67 (3.055)
Surface Area	4.86 (2.193)	4.57 (2.573)	2.33 (0.577)	3.33 (2.517)
Overall opinion	4.29 (2.628)	4.64 (2.561)	2.00 (1.000)	3.00 (2.000)

Population analysed: Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.

Primary outcome: Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities

Time frame: Part B: Baseline up to Week 15

Population analysed: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.

Primary outcome: Part B: Number of Participants With Clinical Laboratory Abnormalities

Time frame: Part B: Baseline up to Week 15

Population analysed: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.

Primary outcome: 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

Population analysed: Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: PF--06473871/Placebo (4* 5 mg/cm)	0 of 0	0 of 0	Not reported
Group 2: PF--06473871/Placebo (3* 5 mg/cm)	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The study was prematurely terminated at the discretion of sponsor as study B5301001 did not meet its pre-defined efficacy endpoints for the dosing regimens evaluated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06473871 in people with Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery, run by Pfizer at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.