A Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or 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), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199

ClinicalTrials.gov processed this data on September 15, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED - HAS RESULTS
(See Contacts and Locations)
Verified September 2023 by Galderma R&D

Sponsor

Galderma R&D

Information Provided by (Responsible Party)

Galderma R&D

Clinicaltrials.gov Identifier

NCT04269395
Other Study ID Numbers: RD.06.SPR.115230
First Submitted: February 10, 2020
First Posted: February 13, 2020
Results First Posted: October 10, 2023
Last Update Posted: October 10, 2023
Last Verified: September 2023
History of Changes

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study Description

This is a double-blind, multicenter, long-term follow-up study. The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream (CD06809-41) or 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), for participants achieving complete response of treated lesions at Final Visit in Study RD.06.SPR.112199 (NCT04085367).
Condition or Disease Intervention/Treatment
  • Keratosis, Actinic
  • Drug: MAL Cream
  • Drug: Vehicle cream

Study Design

Study TypeInterventional
Actual Enrollment125 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposePrevention
Official TitleA Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or 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), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199
Study Start DateApril 7, 2020
Actual Primary Completion DateSeptember 1, 2021
Actual Study Completion DateSeptember 1, 2021

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • MAL Cream Arm
    • Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
  • Drug: MAL Cream
    • No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.
  • Vehicle Cream Arm
    • Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
  • Drug: Vehicle cream

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 [At Week 54]
      Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 54 was reported.

    Secondary Outcome Measures

    1. Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 [At Week 28 and Week 54]
      Recurrence is defined as the percentage of recurrence of cleared treated lesions. Percent recurrence of cleared treated actinic keratosis lesions at Week 28 and Week 54 was reported.
    2. Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 [At Week 28]
      Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 28 was reported.

    Eligibility Criteria

    Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • Participants who have completed earlier study RD.06.SPR.112199 (NCT04085367) and achieved complete response at last visit
    • Participants fully understand and sign an informed consent form (ICF) before any study procedure begins
    • Participants willing and able to perform all study protocol requirements
    Exclusion Criteria
    • Participants developing or experiencing any condition that may not be safe for them or not compliant will be excluded
    • Pertinent not compliant with study conditions or PI instructions during the earlier study - Lumexia Ph 3

    Contacts and Locations

    Sponsors and Collaborators Galderma R&D
    Locations
    • Galderma Investigational Site (Site#8447) | Fort Smith, Arkansas, United States, 72916
    • Galderma Investigational Site (Site#8577) | Encinitas, California, United States, 92024
    • Galderma Investigational Site (Site#8636) | Fountain Valley, California, United States, 92708
    • Galderma Investigational Site (Site#8224) | Fremont, California, United States, 94538
    • Galderma Investigational Site (Site#8778) | Denver, Colorado, United States, 80210
    • Galderma Investigational Site (Site#8440) | Greenwood Village, Colorado, United States, 80111
    • Galderma Investigational Site (Site#8479) | Bradenton, Florida, United States, 34209
    • Galderma Investigational Site (Site#8769) | Lake Worth, Florida, United States, 33461
    • Galderma Investigational Site (8770) | Lehigh Acres, Florida, United States, 33936
    • Galderma Investigational Site (Site#8765) | North Miami Beach, Florida, United States, 33162
    • Galderma Investigational Site (Site#8734) | Pembroke Pines, Florida, United States, 33028
    • Galderma Investigational Site (Site#8529) | Sanford, Florida, United States, 32771
    • Galderma Investigational Site (Site#8126) | West Palm Beach, Florida, United States, 33401
    • Galderma Investigational Site (Site#8667) | Columbus, Georgia, United States, 31904
    • Galderma Investigational Site (Site#8755) | Boise, Idaho, United States, 83704
    • Galderma Investigational Site | Boise, Idaho, United States, 83713
    • Galderma Investigational Site (Site#8838) | Darien, Illinois, United States, 60561
    • Galderma Investigational Site (Site#8724) | Louisville, Kentucky, United States, 40241
    • Galderma Investigational Site (Site#8208) | Beverly, Massachusetts, United States, 01915
    • Galderma Investigational Site (Site#8574) | Clarkston, Michigan, United States, 48346
    • Galderma Investigational Site (Site#8757) | Saint Joseph, Michigan, United States, 49085
    • Galderma Investigational Site | Edina, Minnesota, United States, 55410
    • Galderma Investigational Site | Saint Louis, Missouri, United States, 63141
    • Galderma Investigational Site (Site#8048) | Omaha, Nebraska, United States, 68144
    • Galderma Investigational Site 9Site#8420) | Portsmouth, New Hampshire, United States, 03801
    • Galderma Investigational Site (Site#8759) | Albuquerque, New Mexico, United States, 87102
    • Galderma Investigational Site | Brooklyn, New York, United States, 11209
    • Galderma Investigational Site | New York, New York, United States, 10010
    • Galderma Investigational Site | New York, New York, United States, 10022
    • Galderma Investigational Site | New York, New York, United States, 10029-6501
    • Galderma Investigational Site | New York, New York, United States, 10075
    • Galderma Investigational Site (Site#8566) | Charlotte, North Carolina, United States, 28277
    • Galderma Investigational Site (Site#8595) | Dublin, Ohio, United States, 43016
    • Galderma Investigational Site (Site#8212) | Portland, Oregon, United States, 97210
    • Galderma Investigational Site | Philadelphia, Pennsylvania, United States, 19103
    • Galderma Investigational Site | Pittsburgh, Pennsylvania, United States, 15213
    • Galderma Investigational Site | Sugarloaf, Pennsylvania, United States, 18249
    • Galderma Investigational Site (Site#8777) | Charleston, South Carolina, United States, 29407
    • Galderma Investigational Site (Site#8207) | Nashville, Tennessee, United States, 37215
    • Galderma Investigational Site (Site#8076) | Austin, Texas, United States, 78759
    • Galderma Investigational Site (Site#8139) | College Station, Texas, United States, 77845
    • Galderma Investigational Site (Site#8664) | Frisco, Texas, United States, 75034
    • Galderma Investigational Site (Site#8576) | Houston, Texas, United States, 77056
    • Galderma Investigational Site (Site#8546) | Pflugerville, Texas, United States, 78660
    • Galderma Investigational Site (Site#8776) | Saint George, Utah, United States, 84790
    • Galderma Investigational Site (Site#8761) | Salt Lake City, Utah, United States, 84101
    • Galderma Investigational Site (Site#8672) | Salt Lake City, Utah, United States, 84117
    • Galderma Investigational Site (Site#8057) | Lynchburg, Virginia, United States, 24501
    • Galderma Investigational Site (Site#8779) | Seattle, Washington, United States, 98168
    • Galderma Investigational Site (Site#8760) | Spokane, Washington, United States, 99202
    • Galderma Investigational Site 2(Site#8039) | Spokane, Washington, United States, 99202
    • Galderma Investigational Site (Site#8725) | Morgantown, West Virginia, United States, 26505
    • Galderma Investigational Site (Site#8231) | Aibonito, Puerto Rico, 00705

    Study Documents (Full Text)

    More Information

    Additional Relevant MeSH Terms

    • Keratosis, Actinic
    • Keratosis
    • Recurrence
    • Disease Attributes
    • Pathologic Processes
    • Skin Diseases
    • Precancerous Conditions
    • Neoplasms