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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

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NCT01038297

Last updated on December 16, 2017
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FOR MORE INFORMATION
Study Location
Chicago, Illinois, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Scar Prevention
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01038297
Pfizer
Completed
Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

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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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Scar Prevention
  • Drug: EXC 001
    Intradermal injections of EXC 001 and placebo given on various schedules.
  • Drug: Placebo
    Intradermal injections of EXC 001 and placebo given on various schedules.
  • Experimental: EXC 001
    Intervention: Drug: EXC 001
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01038297
EXC 001-201
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Not Provided
Pfizer
October 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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