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

Stopped early · Phase 2

Conditions studied: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery

In brief

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.

Key facts

Study ID

NCT02205476

Run by

Pfizer

People needed

10

Starts

2014-12-01

Expected to finish

2015-01-01

Last updated by the study team

2016-01-28

Who can join

Age: 18 and older, up to 57. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Where it is running

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

Full record on ClinicalTrials.gov

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