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Safety and Efficacy Study of Different Dose Levels 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:
NCT01038297
First received: December 21, 2009
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

The study will investigate the ability of different dose levels and regimens 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, Dose- Ranging Study to Evaluate Efficacy and Safety of EXC 001 for the Amelioration of Incision Scars in the Abdominal Pannus of Subjects Undergoing an Elective Abdominoplasty

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the relative efficacy of various dosage regimens of EXC 001 for amelioration of scar severity in the abdominal pannus of 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 prior to undergoing an elective abdominoplasty. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EXC 001 Drug: EXC 001
Intradermal injections of EXC 001 and placebo given on various schedules.
Placebo Comparator: Placebo Drug: Placebo
Intradermal injections of EXC 001 and placebo given on various schedules.

  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:

  • Subjects with existing scars or significant striae on the abdominal pannus
  • 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
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: NCT01038297

Locations
United States, Illinois
Chicago, Illinois, United States
United States, Missouri
St. Louis, Missouri, United States
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01038297     History of Changes
Other Study ID Numbers: EXC 001-201
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 November 25, 2014