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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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