Status:
TERMINATED
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
Lead Sponsor:
Pfizer
Conditions:
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Eligibility:
All Genders
18-57 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02205476
Start Date
December 1 2014
End Date
January 1 2015
Last Update
January 28 2016
Active Locations (5)
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1
Stephan Baker MD PA
Coral Gables, Florida, United States, 33146
2
Bayside Ambulatory Center
Miami, Florida, United States, 33133
3
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, United States, 30328
4
Primeter outpatient surgery center
Atlanta, Georgia, United States, 30328