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:
NCT01037413
First received: December 21, 2009
Last updated: October 9, 2012
Last verified: October 2012
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Purpose
The study will investigate the ability of EXC 001 to improve the appearance of scars in subjects undergoing revision of scars resulting from prior breast surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Scar Prevention |
Drug: EXC 001 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel 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 EXC 001 for the Amelioration of Scarring Following Revision of Scars Resulting From Prior Breast Surgery in Adult Female Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To assess the efficacy of EXC 001 in reducing skin scarring in subjects undergoing an elective revision of scars resulting from prior breast surgery. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the safety of EXC 001 in subjects undergoing an elective revision of scars resulting from prior breast surgery. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | November 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: EXC 001 |
Drug: EXC 001
Multiple intradermal injections of EXC 001 and placebo
|
| Placebo Comparator: Placebo |
Drug: Placebo
Multiple intradermal injections of EXC 001 and placebo
|
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 previously had breast surgery resulting in unacceptable scars
- Subject has chosen to have the breast scars revised
- Subjects 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 this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037413
Locations
| United States, California | |
| San Diego, California, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, Oregon | |
| Eugene, Oregon, United States | |
| Portland, Oregon, United States | |
Sponsors and Collaborators
Pfizer
More Information
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01037413 History of Changes |
| Other Study ID Numbers: | EXC 001-203 |
| Study First Received: | December 21, 2009 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Scarring |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013