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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 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Pasadena, California, 91105 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Reduction in Hypertrophic Skin Scarring
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
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 the study.

NCT01346969
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 Various Doses and Regimens of EXC 001 for the Amelioration of Scarring Following Revision of Scars From Prior Breast Surgery in Adult Subjects
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Reduction in Hypertrophic Skin Scarring
  • Drug: EXC 001
    Single-dose administered by injection four different times
  • Drug: EXC 001
    Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
  • 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
  • Drug: EXC 001
    Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
  • Active Comparator: Group 1
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 2
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 3
    Intervention: Drug: EXC 001
  • Placebo Comparator: Group 4
    Intervention: Drug: EXC 001
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
April 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01346969
EXC 001-204
B5301004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

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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1-800-718-1021

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[email protected]



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