Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01730339
First received: November 12, 2012
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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 females.
| Condition | Intervention | Phase |
|---|---|---|
|
Reduction of Hypertrophic Skin Scarring |
Drug: PF-06473871 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-blind, Within-Subject, Placebo Controlled Study to Evaluate the Efficacy and Safety of PF-06473871 in Reducing Hypertrophic Skin Scarring in Female Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Physician Global Assessment (Overall Opinion POSAS) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physician Scar Assessment (Complete POSAS) [ Time Frame: Wks 8, 11, 18 and 24 ] [ Designated as safety issue: No ]
- Patient Global Assessment (Overall Opinion POSAS) [ Time Frame: Wks, 8, 11, 18, and 24 ] [ Designated as safety issue: No ]
- Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) [ Time Frame: Wks 8 and 24 ] [ Designated as safety issue: No ]
- Physician and Patient Photoguide Scar Assessment [ Time Frame: Wks 8, 11, 18 and 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Group 1 |
Drug: PF-06473871
Single dose administered by injection four different times
|
| Active Comparator: Group 2 |
Drug: PF-06473871
Single dose administered by injection three different times
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects must have hypertrohic (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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730339
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, California | |
| Pfizer Investigational Site | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | Recruiting |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | Not yet recruiting |
| Whittier, California, United States, 90602 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Lake Worth, Florida, United States, 33461 | |
| Pfizer Investigational Site | Not yet recruiting |
| Miami, Florida, United States, 33146 | |
| United States, Georgia | |
| Pfizer Investigational Site | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| United States, Missouri | |
| Pfizer Investigational Site | Not yet recruiting |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Pfizer Investigational Site | Recruiting |
| Garden City, New York, United States, 11530 | |
| Pfizer Investigational Site | Not yet recruiting |
| Manhasset, New York, United States, 11030 | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10065 | |
| United States, Oregon | |
| Pfizer Investigational Site | Not yet recruiting |
| Eugene, Oregon, United States, 97401 | |
| Pfizer Investigational Site | Not yet recruiting |
| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Recruiting |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| United States, Washington | |
| Pfizer Investigational Site | Not yet recruiting |
| Mountlake Terrace, Washington, United States, 98043 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01730339 History of Changes |
| Other Study ID Numbers: | B5301001 |
| Study First Received: | November 12, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Skin scarring cicatrix breast scar hypertrophic scar |
Additional relevant MeSH terms:
|
Cicatrix Hypertrophy Keloid Keratosis Cicatrix, Hypertrophic Fibrosis |
Pathologic Processes Pathological Conditions, Anatomical Collagen Diseases Connective Tissue Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013