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

Phase 3

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: MAL 16.8% cream; Drug: MAL Vehicle Cream

• Registration Number: NCT04085367
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2019-09-30
• Primary Completion: 2021-03-03
• Study Completion: 2021-04-07
• Status Verified: 2022-03
• Results First Submitted: 2022-03-01
• Results First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Results First Posted: 2022-04-01
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

Inclusion Criteria

• Participants aged ≥ 18 years at the Screening visit.
• 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

• Participants with pigmented AK in the treatment areas.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAL 16.8% Cream	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 Vehicle 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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Response at Week 12	Week 12	Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lesion Complete Response at Week 12	Baseline, Week 12	Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream.
Percentage of Participants With Partial Response at Week 12	Week 12	Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream.

Trial Locations

Locations (60)

Galderma Investigational Site (Site 8860); 🇺🇸 Atlanta, Georgia, United States

Galderma Investigational Site (Site 8734); 🇺🇸 Pembroke Pines, Florida, United States

Galderma Investigational Site (Site 8595); 🇺🇸 Dublin, Ohio, United States

Galderma Investigational Site (Site 8114); 🇺🇸 Fresno, California, United States

Galderma Investigational Site (Site 8683); 🇺🇸 Atlanta, Georgia, United States

Galderma Investigational Site (Site 8758); 🇺🇸 San Diego, California, United States

Galderma Investigational Site (Site 8656); 🇺🇸 Miami, Florida, United States

Galderma Investigational Site (Site 8721); 🇺🇸 Pittsburgh, Pennsylvania, United States

Galderma Investigational Site (Site # 8576); 🇺🇸 Houston, Texas, United States

Galderma Investigational Site (Site 8672); 🇺🇸 Salt Lake City, Utah, United States

Galderma Investigational Site (Site 8207); 🇺🇸 Nashville, Tennessee, United States

Galderma Investigational Site (Site 8440); 🇺🇸 Greenwood Village, Colorado, United States

Galderma Investigational Site (Site 8768); 🇺🇸 Tucson, Arizona, United States

Galderma Investigational Site (Site 8447); 🇺🇸 Fort Smith, Arkansas, United States

Galderma Investigational Site (Site 8725); 🇺🇸 Morgantown, West Virginia, 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 8608); 🇺🇸 Santa Monica, California, 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 8765); 🇺🇸 North Miami Beach, Florida, United States

Galderma Investigation Site (Site 8769); 🇺🇸 Palm Springs, 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 8838); 🇺🇸 Darien, Illinois, United States

Galderma Investigation Site (Site 8757); 🇺🇸 Saint Joseph, Michigan, United States

Galderma Investigational Site (Site 8208); 🇺🇸 Beverly, Massachusetts, United States

Galderma Investigational Site (Site 8574); 🇺🇸 Clarkston, 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 8420); 🇺🇸 Portsmouth, New Hampshire, United States

Galderma Investigational Site (Site 8242); 🇺🇸 Brooklyn, New York, United States

Galderma Investigational Site (Site 8759); 🇺🇸 Albuquerque, New Mexico, United States

Galderma Investigational Site (Site 8733); 🇺🇸 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 8279); 🇺🇸 New York, New York, United States

Galderma Investigational Site (Site 8255); 🇺🇸 Philadelphia, Pennsylvania, United States

Galderma Investigational Site (Site 8754); 🇺🇸 Sugarloaf, Pennsylvania, 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 8546); 🇺🇸 Pflugerville, Texas, United States

Galderma Investigational Site (Site 8761); 🇺🇸 West Jordan, Utah, United States

Galderma Investigational Site (Site 8776); 🇺🇸 Saint George, 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 8760); 🇺🇸 Spokane, Washington, United States

Galderma Investigational Site (Site 8039); 🇺🇸 Spokane, Washington, United States

Galderma Investigational Site (Site 8231); 🇵🇷 Aibonito, Puerto Rico

Galderma Investigational Site (Site 8755); 🇺🇸 Boise, Idaho, United States

Galderma Investigational Site (Site 8778); 🇺🇸 Denver, Colorado, United States

Galderma Investigational Site (Site 8724); 🇺🇸 Louisville, Kentucky, United States

Galderma Investigational Site (Site 8048); 🇺🇸 Omaha, Nebraska, United States

Galderma Investiational Site (Site 8212); 🇺🇸 Portland, Oregon, United States

Galderma Investigational Site (Site 8777); 🇺🇸 Charleston, South Carolina, United States

Galderma Investigational Site (Site 8076); 🇺🇸 Austin, Texas, United States