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

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)

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).

Study Overview

• Status: Completed
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: MAL 16.8% cream; Drug: MAL Vehicle Cream

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 Type: Interventional
• Enrollment (Actual): 557
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Aibonito, Puerto Rico, 00705
    • Galderma Investigational Site (Site 8231)
• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Galderma Investigational Site (Site 8768)
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916-6103
      • Galderma Investigational Site (Site 8447)
  • California
    • Encinitas, California, United States, 92024
      • Galderma Investigational Site (Site 8577)
    • Fountain Valley, California, United States, 92708
      • Galderma Investigational Site (Site 8636)
    • Fremont, California, United States, 94538
      • Galderma Investigational Site (Site 8224)
    • Fresno, California, United States, 93720
      • Galderma Investigational Site (Site 8114)
    • San Diego, California, United States, 92121
      • Galderma Investigational Site (Site 8758)
    • Santa Monica, California, United States, 90404
      • Galderma Investigational Site (Site 8608)
  • Colorado
    • Denver, Colorado, United States, 80210
      • Galderma Investigational Site (Site 8778)
    • Greenwood Village, Colorado, United States, 80111
      • Galderma Investigational Site (Site 8440)
  • Florida
    • Bradenton, Florida, United States, 34209
      • Galderma Investigational Site (Site 8479)
    • Lehigh Acres, Florida, United States, 33936
      • Galderma Investigational Site (Site 8770)
    • Miami, Florida, United States, 33137
      • Galderma Investigational Site (Site 8656)
    • North Miami Beach, Florida, United States, 33162
      • Galderma Investigational Site (Site 8765)
    • Palm Springs, Florida, United States, 33461
      • Galderma Investigation Site (Site 8769)
    • Pembroke Pines, Florida, United States, 33028
      • Galderma Investigational Site (Site 8734)
    • Sanford, Florida, United States, 32771
      • Galderma Investigational Site (Site 8529)
    • West Palm Beach, Florida, United States, 33401
      • Galderma Investigational Site (Site 8126)
  • Georgia
    • Atlanta, Georgia, United States, 30342-1418
      • Galderma Investigational Site (Site 8683)
    • Atlanta, Georgia, United States, 30342
      • Galderma Investigational Site (Site 8860)
    • Columbus, Georgia, United States, 31904
      • Galderma Investigational Site (Site 8667)
  • Idaho
    • Boise, Idaho, United States, 83704
      • Galderma Investigational Site (Site 8755)
  • Illinois
    • Darien, Illinois, United States, 60561
      • Galderma Investigational Site (Site 8838)
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Galderma Investigational Site (Site 8724)
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Galderma Investigational Site (Site 8208)
  • Michigan
    • Clarkston, Michigan, United States, 48346-3198
      • Galderma Investigational Site (Site 8574)
    • Saint Joseph, Michigan, United States, 49085
      • Galderma Investigation Site (Site 8757)
  • Minnesota
    • Edina, Minnesota, United States, 55424-1200
      • Galderma Investigational Site (Site 8762)
    • New Brighton, Minnesota, United States, 55112
      • Galderma Investigational Site (Site 8140)
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Galderma Investigational Site (Site 8219)
    • Saint Louis, Missouri, United States, 63141
      • Galderma Investigational Site (Site 8869)
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Galderma Investigational Site (Site 8048)
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Galderma Investigational Site (Site 8420)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Galderma Investigational Site (Site 8759)
  • New York
    • Brooklyn, New York, United States, 11203
      • Galderma Investigational Site (Site 8242)
    • New York, New York, United States, 10022
      • Galderma Investigational Site (Site 8733)
    • New York, New York, United States, 10075
      • Galderma Investigational Site (Site 8279)
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Galderma Investigational Site (Site 8566)
    • Wilmington, North Carolina, United States, 28405-3176
      • Galderma Investigational Site (Site 8726)
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Galderma Investigational Site (Site 8595)
  • Oregon
    • Portland, Oregon, United States, 97210-2996
      • Galderma Investiational Site (Site 8212)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Galderma Investigational Site (Site 8255)
    • Pittsburgh, Pennsylvania, United States, 15213
      • Galderma Investigational Site (Site 8721)
    • Sugarloaf, Pennsylvania, United States, 18249
      • Galderma Investigational Site (Site 8754)
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Galderma Investigational Site (Site 8777)
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Galderma Investigational Site (Site 8207)
  • Texas
    • Austin, Texas, United States, 78759
      • Galderma Investigational Site (Site 8076)
    • College Station, Texas, United States, 77845
      • Galderma Investigational Site (Site 8139)
    • Frisco, Texas, United States, 75034
      • Galderma Investigational Site (Site 8664)
    • Houston, Texas, United States, 77056
      • Galderma Investigational Site (Site # 8576)
    • Pflugerville, Texas, United States, 78660-3519
      • Galderma Investigational Site (Site 8546)
  • Utah
    • Saint George, Utah, United States, 84790
      • Galderma Investigational Site (Site 8776)
    • Salt Lake City, Utah, United States, 84117
      • Galderma Investigational Site (Site 8672)
    • West Jordan, Utah, United States, 84101
      • Galderma Investigational Site (Site 8761)
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Galderma Investigational Site (Site 8057)
  • Washington
    • Burien, Washington, United States, 98168
      • Galderma Investigational Site (Site 8779)
    • Spokane, Washington, United States, 99202
      • Galderma Investigational Site (Site 8039)
    • Spokane, Washington, United States, 99202
      • Galderma Investigational Site (Site 8760)
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Galderma Investigational Site (Site 8725)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: MAL 16.8% cream; Day light photodynamic therapy with MAL 16.8% cream; Other Names: CD06809-41
PLACEBO_COMPARATOR: 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.	Drug: MAL Vehicle Cream; Day light photodynamic therapy with MAL vehicle cream

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Lesion Complete Response at 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.	Baseline, Week 12
Percentage of Participants With Partial Response at 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.	Week 12

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): March 3, 2021
• Study Completion (ACTUAL): April 7, 2021

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: RD.06.SPR.112199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No