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Brief Title: 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
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)
Study ID: NCT04085367
Brief Summary: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
Detailed Description: This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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), Saint Louis, Missouri, United States
Galderma Investigational Site (Site 8869), Saint 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 8776), Saint George, Utah, United States
Galderma Investigational Site (Site 8672), Salt Lake City, 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