Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01346969
First received: May 1, 2011
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Reduction in Hypertrophic Skin Scarring |
Drug: EXC 001 |
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 Controlled Study to Evaluate Efficacy and Safety of Various Doses and Regimens of EXC 001 for the Amelioration of Scarring Following Revision of Scars From Prior Breast Surgery in Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Physician Scar Assessment [ Time Frame: Wks 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physician Scar Assessment [ Time Frame: Wks 11, 18 ] [ Designated as safety issue: No ]
- Expert Panel Assessment of Blinded Photographs Uing VAS [ Time Frame: Wks 11, 18, 24 ] [ Designated as safety issue: No ]
- Subject Scar Assessment [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
- Scar Severity Assessment Using a Photonumeric Guide by the Physician and the Subject [ Time Frame: Wk 24 ] [ Designated as safety issue: No ]
| Enrollment: | 68 |
| Study Start Date: | June 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Group 1 |
Drug: EXC 001
Single-dose administered by injection four different times
|
| Placebo Comparator: Group 2 |
Drug: EXC 001
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
|
| Placebo Comparator: Group 3 |
Drug: EXC 001
Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
|
| Placebo Comparator: Group 4 |
Drug: EXC 001
Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have previous had breast surgery resulting in unacceptable scars.
- Subject has chosen to have breast scars revised.
- Subject must not be pregnant or lactating.
Exclusion Criteria:
- Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.
- Participation in another clinical trial within 30 days prior to the start of the study.
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346969
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Pasadena, California, United States, 91105 | |
| Pfizer Investigational Site | |
| Whittier, California, United States, 90602 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Lake Worth, Florida, United States, 33461 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33146 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Montclair, New Jersey, United States, 07042 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| Pfizer Investigational Site | |
| Tualatin, Oregon, United States, 97062 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| 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: | NCT01346969 History of Changes |
| Other Study ID Numbers: | EXC 001-204, B5301004 |
| Study First Received: | May 1, 2011 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Skin scarring cicatrix breast scar |
Additional relevant MeSH terms:
|
Cicatrix Hypertrophy Keloid Keratosis Fibrosis |
Pathologic Processes Pathological Conditions, Anatomical Collagen Diseases Connective Tissue Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013