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PF-06473871

Phase 2

Reduction of Hypertrophic Skin Scarring | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Feb 17, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01730339Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision SurgeryPHASE2 COMPLETED 103 — — Dec 1, 2012Oct 1, 2014Feb 17, 201640 United States, Germany +2
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Study Endpoints
Primary Endpoints
Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
Week 24

Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.

Secondary Endpoints
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Week 8, 11, 18, 24
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Week 8, 11, 18, 24
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Week 8, 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1ACTIVE_COMPARATOR -
Group 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PF-06473871DRUGSingle dose administered by injection four different times
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Subjects must have hypertrophic (raised) breast scars from previous surgery * Subjects must be healthy Exclusion Criteria: * Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding. * Presence of history of breast cancer

Countries:United StatesGermanyHungarySpain
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