Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

• ClinicalTrials.gov Identifier: NCT01037413
• Recruitment Status: Completed
• First Posted: December 23, 2009
• Last Update Posted: October 11, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: December 21, 2009
• First Posted Date: December 23, 2009
• Last Update Posted Date: October 11, 2012
• Study Start Date: November 2009
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 1, 2012): 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 ]
• Original Primary Outcome Measures (submitted: December 22, 2009): To assess the efficacy of EXC 001 in reducing skin scarring in subjects undergoing an elective revision of scars resulting from prior breast surgery.
• Change History: Complete list of historical versions of study NCT01037413 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: March 1, 2012): To assess the safety of EXC 001 in subjects undergoing an elective revision of scars resulting from prior breast surgery. [ Time Frame: 6 months ]
• Original Secondary Outcome Measures (submitted: December 22, 2009): To assess the safety of EXC 001 in subjects undergoing an elective revision of scars resulting from prior breast surgery.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Scar Prevention

Intervention

• Drug: EXC 001
  Multiple intradermal injections of EXC 001 and placebo
• Drug: Placebo
  Multiple intradermal injections of EXC 001 and placebo

Study Arms

• Experimental: EXC 001
  Intervention: Drug: EXC 001
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2012): 25
• Original Estimated Enrollment (submitted: December 22, 2009): 40
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01037413
• Other Study ID Numbers: EXC 001-203
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pfizer
• Verification Date: October 2012