Phase 2
N=100
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Reduction of Hypertrophic Skin Scarring
Bottom Line
View on ClinicalTrials.gov: NCT01730339 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) — 4.00; 4.68; 4.61; 4.86 units on scale — p=0.0219
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-06473871 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) |
4.00; 4.68; 4.61; 4.86 | 0.0219 sig |
| SECONDARY Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) |
3.63; 3.51; 3.95; 3.79; 3.64; 3.83 | 0.2778 |
| SECONDARY Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) |
5.38; 5.48; 5.09; 5.20; 5.58; 5.59 | 0.7552 |
| SECONDARY Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score |
34.95; 36.27; 34.50; 34.14; 43.55; 47.37 | — |
| SECONDARY Physician and Participant Photoguide Scar Assessment Scale Score |
2.35; 2.45; 2.24; 2.28; 2.42; 2.71 | — |
Summary
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01730339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.