A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified August 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 9, 2020
First Posted
February 12, 2020
Results First Posted
May 26, 2023
Last Update Posted
October 9, 2023
Last Verified
August 2023

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Keratosis, Actinic
Drug: MAL CreamDrug: 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 6, 2020
Actual Primary Completion DateAugust 31, 2021
Actual Study Completion DateAugust 31, 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
No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions 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
    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
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 CollaboratorsGalderma R&D
Locations
Galderma Investigational Site (Site#8447) | Fort Smith Arkansas, United States, 72916Galderma Investigational Site (Site#8577) | Encinitas California, United States, 92024Galderma Investigational Site (Site#8636) | Fountain Valley California, United States, 92708Galderma Investigational Site (Site#8224) | Fremont California, United States, 94538Galderma Investigational Site (Site#8778) | Denver Colorado, United States, 80210Galderma Investigational Site (Site#8440) | Greenwood Village Colorado, United States, 80111Galderma Investigational Site (Site#8479) | Bradenton Florida, United States, 34209Galderma Investigational Site (Site#8769) | Lake Worth Florida, United States, 33461Galderma Investigational Site (8770) | Lehigh Acres Florida, United States, 33936Galderma Investigational Site (Site#8765) | North Miami Beach Florida, United States, 33162Galderma Investigational Site (Site#8734) | Pembroke Pines Florida, United States, 33028Galderma Investigational Site (Site#8529) | Sanford Florida, United States, 32771Galderma Investigational Site (Site#8126) | West Palm Beach Florida, United States, 33401Galderma Investigational Site (Site#8667) | Columbus Georgia, United States, 31904Galderma Investigational Site (Site#8755) | Boise Idaho, United States, 83704Galderma Investigational Site | Boise Idaho, United States, 83713Galderma Investigational Site (Site#8838) | Darien Illinois, United States, 60561Galderma Investigational Site (Site#8724) | Louisville Kentucky, United States, 40241Galderma Investigational Site (Site#8208) | Beverly Massachusetts, United States, 01915Galderma Investigational Site (Site#8574) | Clarkston Michigan, United States, 48346Galderma Investigational Site (Site#8757) | Saint Joseph Michigan, United States, 49085Galderma Investigational Site | Edina Minnesota, United States, 55410Galderma Investigational Site | St Louis Missouri, United States, 63141Galderma Investigational Site (Site#8048) | Omaha Nebraska, United States, 68144Galderma Investigational Site 9Site#8420) | Portsmouth New Hampshire, United States, 03801Galderma Investigational Site (Site#8759) | Albuquerque New Mexico, United States, 87102Galderma Investigational Site | Brooklyn New York, United States, 11209Galderma Investigational Site | New York New York, United States, 10010Galderma Investigational Site | New York New York, United States, 10022Galderma Investigational Site | New York New York, United States, 10029-6501Galderma Investigational Site | New York New York, United States, 10075Galderma Investigational Site (Site#8566) | Charlotte North Carolina, United States, 28277Galderma Investigational Site (Site#8595) | Dublin Ohio, United States, 43016Galderma Investigational Site (Site#8212) | Portland Oregon, United States, 97210Galderma Investigational Site | Philadelphia Pennsylvania, United States, 19103Galderma Investigational Site | Pittsburgh Pennsylvania, United States, 15213Galderma Investigational Site | Sugarloaf Pennsylvania, United States, 18249Galderma Investigational Site (Site#8777) | Charleston South Carolina, United States, 29407Galderma Investigational Site (Site#8207) | Nashville Tennessee, United States, 37215Galderma Investigational Site (Site#8076) | Austin Texas, United States, 78759Galderma Investigational Site (Site#8139) | College Station Texas, United States, 77845Galderma Investigational Site (Site#8664) | Frisco Texas, United States, 75034Galderma Investigational Site (Site#8576) | Houston Texas, United States, 77056Galderma Investigational Site (Site#8546) | Pflugerville Texas, United States, 78660Galderma Investigational Site (Site#8761) | Salt Lake City Utah, United States, 84101Galderma Investigational Site (Site#8672) | Salt Lake City Utah, United States, 84117Galderma Investigational Site (Site#8776) | St. George Utah, United States, 84790Galderma Investigational Site (Site#8057) | Lynchburg Virginia, United States, 24501Galderma Investigational Site (Site#8779) | Seattle Washington, United States, 98168Galderma Investigational Site (Site#8760) | Spokane Washington, United States, 99202Galderma Investigational Site 2(Site#8039) | Spokane Washington, United States, 99202Galderma Investigational Site (Site#8725) | Morgantown West Virginia, United States, 26505Galderma Investigational Site (Site#8231) | Aibonito , Puerto Rico, 00705
Study Documents (Full Text)
Documents provided by Galderma R&D: Study Protocol  January 14, 2021Documents provided by Galderma R&D: Statistical Analysis Plan  September 28, 2021