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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
San Diego, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Scar Prevention
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT01037413
Pfizer
Completed
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Scar Prevention
  • Drug: EXC 001
    Multiple intradermal injections of EXC 001 and placebo
  • Drug: Placebo
    Multiple intradermal injections of EXC 001 and placebo
  • 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
25
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01037413
EXC 001-203
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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