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:
NCT01346969
First received: May 1, 2011
Last updated: May 30, 2013
Last verified: January 2013
  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: May 30, 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 April 17, 2014