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Unknown

Group 1 for Keloid

Phase 2
Waitlist Available
Research Sponsored by Pfizer
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
No Placebo-Only Group

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
  • Keloid

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks after initial scar revision surgery in study b5301001
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks after initial scar revision surgery in study b5301001 for reporting.

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 more
Secondary 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
4,661 Previous Clinical Trials
17,844,979 Total Patients Enrolled
1 Trials studying Keloid
30 Patients Enrolled for Keloid
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,886,135 Total Patients Enrolled
~1 spots leftby Nov 2025
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