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

NCT01346969

Last updated date
Study Location
Pfizer Investigational Site
Pasadena, California, 91105, United States
Contact
1-800-718-1021

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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.

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Reduction in Hypertrophic Skin ScarringSafety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
NCT01346969
  1. Pasadena, California
  2. Whittier, California
  3. Lake Worth, Florida
  4. Miami, Florida
  5. St. Louis, Missouri
  6. Montclair, New Jersey
  7. Eugene, Oregon
  8. Tualatin, Oregon
  9. San Antonio, Texas
  10. Mountlake Terrace, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Reduction in Hypertrophic Skin Scarring
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2011)
68
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2011)
56
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01346969
Other Study ID Numbers  ICMJE EXC 001-204
B5301004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP