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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

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

PF-06473871 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT01730339Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision SurgeryReduction of Hypertrophic Skin Scarring
COMPLETED103 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Reduction of Hypertrophic Skin ScarringUnlock trial analytics

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.

Incidence of Adverse events
6 weeks

will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

ECGs
6 weeks

will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

Blood pressure
6 weeks

will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

pulse rate
6 weeks

will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

Injection siter reaction
6 weeks

The number and percentage of subjects that experienced injection site reactions will be analyzed.

number of subjects with adverse events
6 weeks

will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

severity of adverse events
6 weeks

will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

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 -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -

Interventions

NameTypeDescription
PF-06473871DRUGSingle dose administered by injection four different times
80 mg PF-06473871DRUG80 mg of PF-06473871 or placebo
160 mg PF-06473871DRUG160 mg of PF-06473871 or placebo
320 mg PF-06473871DRUG320 mg of PF-06473871 or placebo
480 mg PF-06473871DRUG480 mg of PF-06473871 or placebo
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Eligibility Criteria

Age Range18 Years to 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 StatesGermanyHungarySpainBelgium
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Frequently asked questions about PF-06473871

What is PF-06473871 used for?

PF-06473871 is an investigational small molecule being studied for the reduction of hypertrophic skin scarring and in healthy adults. It is developed by Pfizer, Inc. (PFE). The drug is not approved and remains in clinical development.

Who makes PF-06473871?

PF-06473871 is developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy for reducing hypertrophic skin scarring.

What phase is PF-06473871 in?

PF-06473871 is in clinical development. One completed trial was a Phase 2 study for reducing hypertrophic scars, and another was a Phase 1 study in healthy adults. The drug is investigational and not yet approved.

What clinical trials is PF-06473871 in?

PF-06473871 has two completed trials: NCT01730339, a Phase 2 study in 103 patients for reducing hypertrophic scars from recurring post-revision surgery, and NCT01753791, a Phase 1 study in 32 healthy adults in Belgium.

Is PF-06473871 the same as any other drug?

No alternative names for PF-06473871 have been disclosed. It is identified solely by its compound number in clinical trial records.