Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
NCT ID: NCT04085367
Last Updated: 2022-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
557 participants
INTERVENTIONAL
2019-09-30
2021-04-07
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
TREATMENT
TRIPLE
Study Groups
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MAL 16.8% Cream
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \[DL-PDT\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
MAL 16.8% cream
Day light photodynamic therapy with MAL 16.8% cream
MAL Vehicle Cream
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
MAL Vehicle Cream
Day light photodynamic therapy with MAL vehicle cream
Interventions
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MAL 16.8% cream
Day light photodynamic therapy with MAL 16.8% cream
MAL Vehicle Cream
Day light photodynamic therapy with MAL vehicle cream
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp.
* Female Participants of non-childbearing potential.
* Participants fully understood and signed an ICF before any investigational procedure(s) are performed.
Exclusion Criteria
* Female participants who were pregnant, nursing, or planning a pregnancy during the study.
* Participants with a clinical diagnosis of a skin disease other than AK.
* Immunocompromised participants.
* Participants with any condition that may be associated with a risk of poor protocol compliance.
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 8768)
Tucson, Arizona, United States
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 8114)
Fresno, California, United States
Galderma Investigational Site (Site 8758)
San Diego, California, United States
Galderma Investigational Site (Site 8608)
Santa Monica, 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 8770)
Lehigh Acres, Florida, United States
Galderma Investigational Site (Site 8656)
Miami, Florida, United States
Galderma Investigational Site (Site 8765)
North Miami Beach, Florida, United States
Galderma Investigation Site (Site 8769)
Palm Springs, 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 8683)
Atlanta, Georgia, United States
Galderma Investigational Site (Site 8860)
Atlanta, Georgia, United States
Galderma Investigational Site (Site 8667)
Columbus, Georgia, United States
Galderma Investigational Site (Site 8755)
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 Investigation Site (Site 8757)
Saint Joseph, Michigan, United States
Galderma Investigational Site (Site 8762)
Edina, Minnesota, United States
Galderma Investigational Site (Site 8140)
New Brighton, Minnesota, United States
Galderma Investigational Site (Site 8219)
St Louis, Missouri, United States
Galderma Investigational Site (Site 8869)
St Louis, Missouri, United States
Galderma Investigational Site (Site 8048)
Omaha, Nebraska, United States
Galderma Investigational Site (Site 8420)
Portsmouth, New Hampshire, United States
Galderma Investigational Site (Site 8759)
Albuquerque, New Mexico, United States
Galderma Investigational Site (Site 8242)
Brooklyn, New York, United States
Galderma Investigational Site (Site 8733)
New York, New York, United States
Galderma Investigational Site (Site 8279)
New York, New York, United States
Galderma Investigational Site (Site 8566)
Charlotte, North Carolina, United States
Galderma Investigational Site (Site 8726)
Wilmington, North Carolina, United States
Galderma Investigational Site (Site 8595)
Dublin, Ohio, United States
Galderma Investiational Site (Site 8212)
Portland, Oregon, United States
Galderma Investigational Site (Site 8255)
Philadelphia, Pennsylvania, United States
Galderma Investigational Site (Site 8721)
Pittsburgh, Pennsylvania, United States
Galderma Investigational Site (Site 8754)
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 8672)
Salt Lake City, Utah, United States
Galderma Investigational Site (Site 8776)
St. George, Utah, United States
Galderma Investigational Site (Site 8761)
West Jordan, Utah, United States
Galderma Investigational Site (Site 8057)
Lynchburg, Virginia, United States
Galderma Investigational Site (Site 8779)
Burien, Washington, United States
Galderma Investigational Site (Site 8039)
Spokane, Washington, United States
Galderma Investigational Site (Site 8760)
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.112199
Identifier Type: -
Identifier Source: org_study_id
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