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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

Primary Purpose

Keratosis, Actinic

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MAL Cream
Vehicle cream
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keratosis, Actinic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Galderma Investigational Site (Site#8447)
  • Galderma Investigational Site (Site#8577)
  • Galderma Investigational Site (Site#8636)
  • Galderma Investigational Site (Site#8224)
  • Galderma Investigational Site (Site#8778)
  • Galderma Investigational Site (Site#8440)
  • Galderma Investigational Site (Site#8479)
  • Galderma Investigational Site (Site#8769)
  • Galderma Investigational Site (8770)
  • Galderma Investigational Site (Site#8765)
  • Galderma Investigational Site (Site#8734)
  • Galderma Investigational Site (Site#8529)
  • Galderma Investigational Site (Site#8126)
  • Galderma Investigational Site (Site#8667)
  • Galderma Investigational Site (Site#8755)
  • Galderma Investigational Site
  • Galderma Investigational Site (Site#8838)
  • Galderma Investigational Site (Site#8724)
  • Galderma Investigational Site (Site#8208)
  • Galderma Investigational Site (Site#8574)
  • Galderma Investigational Site (Site#8757)
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site (Site#8048)
  • Galderma Investigational Site 9Site#8420)
  • Galderma Investigational Site (Site#8759)
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site (Site#8566)
  • Galderma Investigational Site (Site#8595)
  • Galderma Investigational Site (Site#8212)
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site (Site#8777)
  • Galderma Investigational Site (Site#8207)
  • Galderma Investigational Site (Site#8076)
  • Galderma Investigational Site (Site#8139)
  • Galderma Investigational Site (Site#8664)
  • Galderma Investigational Site (Site#8576)
  • Galderma Investigational Site (Site#8546)
  • Galderma Investigational Site (Site#8776)
  • Galderma Investigational Site (Site#8761)
  • Galderma Investigational Site (Site#8672)
  • Galderma Investigational Site (Site#8057)
  • Galderma Investigational Site (Site#8779)
  • Galderma Investigational Site (Site#8760)
  • Galderma Investigational Site 2(Site#8039)
  • Galderma Investigational Site (Site#8725)
  • Galderma Investigational Site (Site#8231)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MAL Cream Arm

Vehicle Cream Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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.
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.

Full Information

First Posted
February 10, 2020
Last Updated
September 15, 2023
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04269395
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early as per Sponsor's decision
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAL Cream Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vehicle Cream Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MAL Cream
Other Intervention Name(s)
CD06809-41
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54
Description
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.
Time Frame
At Week 54
Secondary Outcome Measure Information:
Title
Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54
Description
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.
Time Frame
At Week 28 and Week 54
Title
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28
Description
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.
Time Frame
At Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Galderma Investigational Site (Site#8447)
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Galderma Investigational Site (Site#8577)
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Galderma Investigational Site (Site#8636)
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Galderma Investigational Site (Site#8224)
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Galderma Investigational Site (Site#8778)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Galderma Investigational Site (Site#8440)
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Galderma Investigational Site (Site#8479)
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Galderma Investigational Site (Site#8769)
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Galderma Investigational Site (8770)
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33936
Country
United States
Facility Name
Galderma Investigational Site (Site#8765)
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Galderma Investigational Site (Site#8734)
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Galderma Investigational Site (Site#8529)
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Galderma Investigational Site (Site#8126)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Galderma Investigational Site (Site#8667)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Galderma Investigational Site (Site#8755)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Galderma Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Galderma Investigational Site (Site#8838)
City
Darien
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Facility Name
Galderma Investigational Site (Site#8724)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Galderma Investigational Site (Site#8208)
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Galderma Investigational Site (Site#8574)
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Galderma Investigational Site (Site#8757)
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Galderma Investigational Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55410
Country
United States
Facility Name
Galderma Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Galderma Investigational Site (Site#8048)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Galderma Investigational Site 9Site#8420)
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Galderma Investigational Site (Site#8759)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Galderma Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029-6501
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Galderma Investigational Site (Site#8566)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Galderma Investigational Site (Site#8595)
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Galderma Investigational Site (Site#8212)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Galderma Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Galderma Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Galderma Investigational Site
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Facility Name
Galderma Investigational Site (Site#8777)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Galderma Investigational Site (Site#8207)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Galderma Investigational Site (Site#8076)
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Galderma Investigational Site (Site#8139)
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Galderma Investigational Site (Site#8664)
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Galderma Investigational Site (Site#8576)
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Galderma Investigational Site (Site#8546)
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Galderma Investigational Site (Site#8776)
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Galderma Investigational Site (Site#8761)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Facility Name
Galderma Investigational Site (Site#8672)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Galderma Investigational Site (Site#8057)
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Galderma Investigational Site (Site#8779)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98168
Country
United States
Facility Name
Galderma Investigational Site (Site#8760)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Galderma Investigational Site 2(Site#8039)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Galderma Investigational Site (Site#8725)
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Galderma Investigational Site (Site#8231)
City
Aibonito
ZIP/Postal Code
00705
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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