Clinical trial NCT02205476: A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Keywords: Phase 2
open-label
safety
hypertrophic scar revision surgery
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Primary outcomes:
measure: 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
measure: Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Part B: Baseline up to Week 15
measure: Part B: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Part B: Baseline up to Week 15
measure: Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
timeFrame: Part B: Baseline up to Week 15
Secondary outcomes:
measure: Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
timeFrame: 52 weeks after initial scar revision surgery in study B5301001
measure: Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit
timeFrame: 52 weeks after initial scar revision surgery in study B5301001
measure: Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
timeFrame: 52 weeks after initial scar revision surgery in study B5301001
Other outcomes:
measure: Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit
timeFrame: 52 weeks after initial scar revision surgery in study B5301001
Locations:
city: Coral Gables
country: United States
facility: Stephan Baker MD PA
state: Florida
city: Miami
country: United States
facility: Bayside Ambulatory Center
state: Florida
city: Atlanta
country: United States
facility: Kavali Plastic Surgery and Skin Renewal Center
state: Georgia
city: Atlanta
country: United States
facility: Primeter outpatient surgery center
state: Georgia
city: Saint Louis
country: United States
facility: Body Aesthetic Research Center
state: Missouri
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: