A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study
NCT ID: NCT04269395
Last Updated: 2023-10-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
125 participants
INTERVENTIONAL
2020-04-07
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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MAL Cream Arm
Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
MAL Cream
No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.
Vehicle Cream Arm
Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
Vehicle cream
No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.
Interventions
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MAL Cream
No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.
Vehicle cream
No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants fully understand and sign an informed consent form (ICF) before any study procedure begins
* Participants willing and able to perform all study protocol requirements
Exclusion Criteria
* Pertinent not compliant with study conditions or PI instructions during the earlier study - Lumexia Ph 3
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Investigational Site (Site#8447)
Fort Smith, Arkansas, United States
Galderma Investigational Site (Site#8577)
Encinitas, California, United States
Galderma Investigational Site (Site#8636)
Fountain Valley, California, United States
Galderma Investigational Site (Site#8224)
Fremont, California, United States
Galderma Investigational Site (Site#8778)
Denver, Colorado, United States
Galderma Investigational Site (Site#8440)
Greenwood Village, Colorado, United States
Galderma Investigational Site (Site#8479)
Bradenton, Florida, United States
Galderma Investigational Site (Site#8769)
Lake Worth, Florida, United States
Galderma Investigational Site (8770)
Lehigh Acres, Florida, United States
Galderma Investigational Site (Site#8765)
North Miami Beach, Florida, United States
Galderma Investigational Site (Site#8734)
Pembroke Pines, Florida, United States
Galderma Investigational Site (Site#8529)
Sanford, Florida, United States
Galderma Investigational Site (Site#8126)
West Palm Beach, Florida, United States
Galderma Investigational Site (Site#8667)
Columbus, Georgia, United States
Galderma Investigational Site (Site#8755)
Boise, Idaho, United States
Galderma Investigational Site
Boise, Idaho, United States
Galderma Investigational Site (Site#8838)
Darien, Illinois, United States
Galderma Investigational Site (Site#8724)
Louisville, Kentucky, United States
Galderma Investigational Site (Site#8208)
Beverly, Massachusetts, United States
Galderma Investigational Site (Site#8574)
Clarkston, Michigan, United States
Galderma Investigational Site (Site#8757)
Saint Joseph, Michigan, United States
Galderma Investigational Site
Edina, Minnesota, United States
Galderma Investigational Site
St Louis, Missouri, United States
Galderma Investigational Site (Site#8048)
Omaha, Nebraska, United States
Galderma Investigational Site 9Site#8420)
Portsmouth, New Hampshire, United States
Galderma Investigational Site (Site#8759)
Albuquerque, New Mexico, United States
Galderma Investigational Site
Brooklyn, New York, United States
Galderma Investigational Site
New York, New York, United States
Galderma Investigational Site
New York, New York, United States
Galderma Investigational Site
New York, New York, United States
Galderma Investigational Site
New York, New York, United States
Galderma Investigational Site (Site#8566)
Charlotte, North Carolina, United States
Galderma Investigational Site (Site#8595)
Dublin, Ohio, United States
Galderma Investigational Site (Site#8212)
Portland, Oregon, United States
Galderma Investigational Site
Philadelphia, Pennsylvania, United States
Galderma Investigational Site
Pittsburgh, Pennsylvania, United States
Galderma Investigational Site
Sugarloaf, Pennsylvania, United States
Galderma Investigational Site (Site#8777)
Charleston, South Carolina, United States
Galderma Investigational Site (Site#8207)
Nashville, Tennessee, United States
Galderma Investigational Site (Site#8076)
Austin, Texas, United States
Galderma Investigational Site (Site#8139)
College Station, Texas, United States
Galderma Investigational Site (Site#8664)
Frisco, Texas, United States
Galderma Investigational Site (Site#8576)
Houston, Texas, United States
Galderma Investigational Site (Site#8546)
Pflugerville, Texas, United States
Galderma Investigational Site (Site#8761)
Salt Lake City, Utah, United States
Galderma Investigational Site (Site#8672)
Salt Lake City, Utah, United States
Galderma Investigational Site (Site#8776)
St. George, Utah, United States
Galderma Investigational Site (Site#8057)
Lynchburg, Virginia, United States
Galderma Investigational Site (Site#8779)
Seattle, Washington, United States
Galderma Investigational Site (Site#8760)
Spokane, Washington, United States
Galderma Investigational Site 2(Site#8039)
Spokane, Washington, United States
Galderma Investigational Site (Site#8725)
Morgantown, West Virginia, United States
Galderma Investigational Site (Site#8231)
Aibonito, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.06.SPR.115230
Identifier Type: -
Identifier Source: org_study_id
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