Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks after initial scar revision surgery in study b5301001
Awards & highlights
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.
Eligible Conditions
- Hypertrophic Scar
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks after initial scar revision surgery in study b5301001
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks after initial scar revision surgery in study b5301001
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part B: Number of Participants With Clinical Laboratory Abnormalities
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
+1 moreSecondary study objectives
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit
Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
Other study objectives
Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
Group II: Group 1Experimental Treatment1 Intervention
The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06473871
2012
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,631 Previous Clinical Trials
17,733,324 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,523 Previous Clinical Trials
14,907,230 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger