Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01494922
First received: December 15, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
| Condition | Intervention | Phase |
|---|---|---|
|
Reduction in Severity of Skin Scarring |
Drug: EXC 001 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Open-label Study to Provide Revision of Scars Resulting From Surgery in Prior Studies of EXC 001 (Currently Called PF-06473871) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Assess the safety of EXC 001 in subjects undergoing elective revision of scars from prior surgery [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physician Scar Assessment Scale [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
- Subject Scar Assessment Scale [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
- Physician Reported Scar Severity Scale (Photonumeric Guide) [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
- Subject Reported Scar Severity Scale (Photonumeric Guide) [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open Label |
Drug: EXC 001
Single dose administered by injection at four different times
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy adults who have participated in previous studies of EXC 001.
- Healthy adults who have chosen to have their scars revised.
Exclusion Criteria:
- Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding.
- Participation in another clinical trial within 30 days prior to the start of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494922
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Lake Worth, Florida, United States, 33461 | |
| United States, Illinois | |
| Pfizer Investigational Site | Completed |
| Chicago, Illinois, United States, 60611 | |
| United States, Oregon | |
| Pfizer Investigational Site | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Pfizer Investigational Site | Recruiting |
| Tualatin, Oregon, United States, 97062 | |
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: | NCT01494922 History of Changes |
| Other Study ID Numbers: | EXC 001-206, B5301003 |
| Study First Received: | December 15, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Skin scarring cicatrix hypertrophic scar hypertrophic scar prevention |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013