Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
NCT ID: NCT01346969
Last Updated: 2021-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2011-06-01
2012-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Study Groups
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Group 1
EXC 001
Single-dose administered by injection four different times
Group 2
EXC 001
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
Group 3
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
Group 4
EXC 001
Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Interventions
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EXC 001
Single-dose administered by injection four different times
EXC 001
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
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
EXC 001
Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Eligibility Criteria
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Inclusion Criteria
* Subject has chosen to have breast scars revised.
* Subject must not be pregnant or lactating.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Skin Deep Laser Medical Spa
Pasadena, California, United States
Bright Health Physicans Plastic Surgery and Aesthetic Medicine
Whittier, California, United States
Altus Research
Lake Worth, Florida, United States
Bayside Ambulatory Center
Miami, Florida, United States
Aesthetic Plastic Surgery Miami
Miami, Florida, United States
Body Aesthetic Plastic Surgery
St Louis, Missouri, United States
New Jersey Plastic Surgery
Montclair, New Jersey, United States
Mark L. Jewell,MD Surgery Center
Eugene, Oregon, United States
Connall Consmetic Surgery
Tualatin, Oregon, United States
Endeavor Clinical Trials,P.A.
San Antonio, Texas, United States
Texas Plastic Surgery
San Antonio, Texas, United States
BAXTER Plastic Surgery
Mountlake Terrace, Washington, United States
Countries
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Related Links
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Other Identifiers
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B5301004
Identifier Type: OTHER
Identifier Source: secondary_id
EXC 001-204
Identifier Type: -
Identifier Source: org_study_id
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