TerminatedPhase 2

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

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.

United States10 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range

18 Years – 57 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit

Timeframe: 52 weeks after initial scar revision surgery in study B5301001

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

Timeframe: Part B: Baseline up to Week 15

Part B: Number of Participants With Clinical Laboratory Abnormalities

Timeframe: Part B: Baseline up to Week 15

Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

Timeframe: Part B: Baseline up to Week 15

Trial details

NCT IDNCT02205476

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2015-12-21

View on ClinicalTrials.gov More Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery trials

Who can participate

Age range

18 Years – 57 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit

Timeframe: 52 weeks after initial scar revision surgery in study B5301001

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

Timeframe: Part B: Baseline up to Week 15

Part B: Number of Participants With Clinical Laboratory Abnormalities

Timeframe: Part B: Baseline up to Week 15

Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

Timeframe: Part B: Baseline up to Week 15