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 range18 Years – 57 Years

SexALL

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intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

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 range18 Years – 57 Years

SexALL

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