search
Back to results

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

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MAL 16.8% cream
MAL Vehicle Cream
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

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

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.

Sites / Locations

  • Galderma Investigational Site (Site 8768)
  • Galderma Investigational Site (Site 8447)
  • Galderma Investigational Site (Site 8577)
  • Galderma Investigational Site (Site 8636)
  • Galderma Investigational Site (Site 8224)
  • Galderma Investigational Site (Site 8114)
  • Galderma Investigational Site (Site 8758)
  • Galderma Investigational Site (Site 8608)
  • Galderma Investigational Site (Site 8778)
  • Galderma Investigational Site (Site 8440)
  • Galderma Investigational Site (Site 8479)
  • Galderma Investigational Site (Site 8770)
  • Galderma Investigational Site (Site 8656)
  • Galderma Investigational Site (Site 8765)
  • Galderma Investigation Site (Site 8769)
  • Galderma Investigational Site (Site 8734)
  • Galderma Investigational Site (Site 8529)
  • Galderma Investigational Site (Site 8126)
  • Galderma Investigational Site (Site 8683)
  • Galderma Investigational Site (Site 8860)
  • Galderma Investigational Site (Site 8667)
  • Galderma Investigational Site (Site 8755)
  • Galderma Investigational Site (Site 8838)
  • Galderma Investigational Site (Site 8724)
  • Galderma Investigational Site (Site 8208)
  • Galderma Investigational Site (Site 8574)
  • Galderma Investigation Site (Site 8757)
  • Galderma Investigational Site (Site 8762)
  • Galderma Investigational Site (Site 8140)
  • Galderma Investigational Site (Site 8219)
  • Galderma Investigational Site (Site 8869)
  • Galderma Investigational Site (Site 8048)
  • Galderma Investigational Site (Site 8420)
  • Galderma Investigational Site (Site 8759)
  • Galderma Investigational Site (Site 8242)
  • Galderma Investigational Site (Site 8733)
  • Galderma Investigational Site (Site 8279)
  • Galderma Investigational Site (Site 8566)
  • Galderma Investigational Site (Site 8726)
  • Galderma Investigational Site (Site 8595)
  • Galderma Investiational Site (Site 8212)
  • Galderma Investigational Site (Site 8255)
  • Galderma Investigational Site (Site 8721)
  • Galderma Investigational Site (Site 8754)
  • 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 8672)
  • Galderma Investigational Site (Site 8761)
  • Galderma Investigational Site (Site 8057)
  • Galderma Investigational Site (Site 8779)
  • Galderma Investigational Site (Site 8039)
  • Galderma Investigational Site (Site 8760)
  • Galderma Investigational Site (Site 8725)
  • Galderma Investigational Site (Site 8231)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MAL 16.8% Cream

MAL Vehicle Cream

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 9, 2019
Last Updated
March 7, 2022
Sponsor
Galderma R&D
search

1. Study Identification

Unique Protocol Identification Number
NCT04085367
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
March 3, 2021 (Actual)
Study Completion Date
April 7, 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
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).
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
557 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAL 16.8% Cream
Arm Type
Experimental
Arm Description
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.
Arm Title
MAL Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MAL 16.8% cream
Other Intervention Name(s)
CD06809-41
Intervention Description
Day light photodynamic therapy with MAL 16.8% cream
Intervention Type
Drug
Intervention Name(s)
MAL Vehicle Cream
Intervention Description
Day light photodynamic therapy with MAL vehicle cream
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response at Week 12
Description
Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lesion Complete Response at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With Partial Response at Week 12
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Galderma Investigational Site (Site 8768)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Galderma Investigational Site (Site 8447)
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916-6103
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 8114)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Galderma Investigational Site (Site 8758)
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Galderma Investigational Site (Site 8608)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
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 8770)
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33936
Country
United States
Facility Name
Galderma Investigational Site (Site 8656)
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
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 Investigation Site (Site 8769)
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
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 8683)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1418
Country
United States
Facility Name
Galderma Investigational Site (Site 8860)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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 (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
48346-3198
Country
United States
Facility Name
Galderma Investigation Site (Site 8757)
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Galderma Investigational Site (Site 8762)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424-1200
Country
United States
Facility Name
Galderma Investigational Site (Site 8140)
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Galderma Investigational Site (Site 8219)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Galderma Investigational Site (Site 8869)
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 (Site 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 (Site 8242)
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Galderma Investigational Site (Site 8733)
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Galderma Investigational Site (Site 8279)
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 8726)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405-3176
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 Investiational Site (Site 8212)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210-2996
Country
United States
Facility Name
Galderma Investigational Site (Site 8255)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Galderma Investigational Site (Site 8721)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Galderma Investigational Site (Site 8754)
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
78660-3519
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 8672)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Galderma Investigational Site (Site 8761)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84101
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
Burien
State/Province
Washington
ZIP/Postal Code
98168
Country
United States
Facility Name
Galderma Investigational Site (Site 8039)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
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 (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

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

We'll reach out to this number within 24 hrs