Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
NCT01037413
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- San Diego, California
- Chicago, Illinois
- St. Louis, Missouri
- Eugene, Oregon
- Portland, Oregon
- San Diego, California
- Chicago, Illinois
- St. Louis, Missouri
- Eugene, Oregon
- Portland, Oregon
- Chicago, Illinois
- St. Louis, Missouri
Descriptive Information | |||
---|---|---|---|
Brief Title ICMJE | Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery | ||
Official Title ICMJE | 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 | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||
Condition ICMJE | Scar Prevention | ||
Intervention ICMJE |
| ||
Study Arms ICMJE |
| ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE | 25 | ||
Original Estimated Enrollment ICMJE | 40 | ||
Actual Study Completion Date ICMJE | December 2010 | ||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 18 Years to 55 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01037413 | ||
Other Study ID Numbers ICMJE | EXC 001-203 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Pfizer | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Pfizer | ||
Verification Date | October 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |