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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01037413
First received: December 21, 2009
Last updated: October 9, 2012
Last verified: October 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014