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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01037985
First received: December 21, 2009
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

The study will investigate the ability of EXC 001 to improve the appearance of scars in subjects undergoing an elective abdominoplasty. The study will also evaluate the safety and tolerability of EXC 001.


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 of the Surgical Incision in Subjects Undergoing an Elective Abdominoplasty

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the efficacy of EXC 001 on reducing scar severity in subjects undergoing an elective abdominoplasty [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of EXC 001 in subjects undergoing an elective abdominoplasty [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 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 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
  • Subject has chosen to have an elective abdominoplasty
  • Medically healthy with normal screening results
  • Subjects must not be pregnant or lactating

Exclusion Criteria:

  • Females who are currently pregnant or pregnant during the 12 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: NCT01037985

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: NCT01037985     History of Changes
Other Study ID Numbers: EXC 001-202
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 May 22, 2013