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

September 15, 2023 updated by: Galderma R&D

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

The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Aibonito, Puerto Rico, 00705
        • Galderma Investigational Site (Site#8231)
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • 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)
    • 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)
      • Lake Worth, Florida, United States, 33461
        • Galderma Investigational Site (Site#8769)
      • Lehigh Acres, Florida, United States, 33936
        • Galderma Investigational Site (8770)
      • North Miami Beach, Florida, United States, 33162
        • Galderma Investigational Site (Site#8765)
      • 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
      • Columbus, Georgia, United States, 31904
        • Galderma Investigational Site (Site#8667)
    • Idaho
      • Boise, Idaho, United States, 83704
        • Galderma Investigational Site (Site#8755)
      • Boise, Idaho, United States, 83713
        • Galderma Investigational Site
    • 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
        • Galderma Investigational Site (Site#8574)
      • Saint Joseph, Michigan, United States, 49085
        • Galderma Investigational Site (Site#8757)
    • Minnesota
      • Edina, Minnesota, United States, 55410
        • Galderma Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Galderma Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Galderma Investigational Site (Site#8048)
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Galderma Investigational Site 9Site#8420)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Galderma Investigational Site (Site#8759)
    • New York
      • 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
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Galderma Investigational Site (Site#8566)
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Galderma Investigational Site (Site#8595)
    • Oregon
      • Portland, Oregon, United States, 97210
        • Galderma Investigational Site (Site#8212)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Galderma Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Galderma Investigational Site
      • Sugarloaf, Pennsylvania, United States, 18249
        • Galderma Investigational Site
    • 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
        • Galderma Investigational Site (Site#8546)
    • Utah
      • Saint George, Utah, United States, 84790
        • Galderma Investigational Site (Site#8776)
      • Salt Lake City, Utah, United States, 84101
        • Galderma Investigational Site (Site#8761)
      • Salt Lake City, Utah, United States, 84117
        • Galderma Investigational Site (Site#8672)
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Galderma Investigational Site (Site#8057)
    • Washington
      • Seattle, Washington, United States, 98168
        • Galderma Investigational Site (Site#8779)
      • Spokane, Washington, United States, 99202
        • Galderma Investigational Site (Site#8760)
      • Spokane, Washington, United States, 99202
        • Galderma Investigational Site 2(Site#8039)
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Galderma Investigational Site (Site#8725)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other Names:
  • CD06809-41
Placebo Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54
Time Frame: 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.
At Week 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54
Time Frame: 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.
At Week 28 and Week 54
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28
Time Frame: 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.
At Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.06.SPR.115230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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