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

March 7, 2022 updated by: Galderma R&D

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
557

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Galderma Investigational Site (Site 8768)
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916-6103
        • 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)
      • Fresno, California, United States, 93720
        • Galderma Investigational Site (Site 8114)
      • San Diego, California, United States, 92121
        • Galderma Investigational Site (Site 8758)
      • Santa Monica, California, United States, 90404
        • Galderma Investigational Site (Site 8608)
    • 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)
      • Lehigh Acres, Florida, United States, 33936
        • Galderma Investigational Site (Site 8770)
      • Miami, Florida, United States, 33137
        • Galderma Investigational Site (Site 8656)
      • North Miami Beach, Florida, United States, 33162
        • Galderma Investigational Site (Site 8765)
      • Palm Springs, Florida, United States, 33461
        • Galderma Investigation Site (Site 8769)
      • 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
      • Atlanta, Georgia, United States, 30342-1418
        • Galderma Investigational Site (Site 8683)
      • Atlanta, Georgia, United States, 30342
        • Galderma Investigational Site (Site 8860)
      • Columbus, Georgia, United States, 31904
        • Galderma Investigational Site (Site 8667)
    • Idaho
      • Boise, Idaho, United States, 83704
        • Galderma Investigational Site (Site 8755)
    • 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, 48346-3198
        • Galderma Investigational Site (Site 8574)
      • Saint Joseph, Michigan, United States, 49085
        • Galderma Investigation Site (Site 8757)
    • Minnesota
      • Edina, Minnesota, United States, 55424-1200
        • Galderma Investigational Site (Site 8762)
      • New Brighton, Minnesota, United States, 55112
        • Galderma Investigational Site (Site 8140)
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Galderma Investigational Site (Site 8219)
      • Saint Louis, Missouri, United States, 63141
        • Galderma Investigational Site (Site 8869)
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Galderma Investigational Site (Site 8048)
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Galderma Investigational Site (Site 8420)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Galderma Investigational Site (Site 8759)
    • New York
      • Brooklyn, New York, United States, 11203
        • Galderma Investigational Site (Site 8242)
      • New York, New York, United States, 10022
        • Galderma Investigational Site (Site 8733)
      • New York, New York, United States, 10075
        • Galderma Investigational Site (Site 8279)
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Galderma Investigational Site (Site 8566)
      • Wilmington, North Carolina, United States, 28405-3176
        • Galderma Investigational Site (Site 8726)
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Galderma Investigational Site (Site 8595)
    • Oregon
      • Portland, Oregon, United States, 97210-2996
        • Galderma Investiational Site (Site 8212)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Galderma Investigational Site (Site 8255)
      • Pittsburgh, Pennsylvania, United States, 15213
        • Galderma Investigational Site (Site 8721)
      • Sugarloaf, Pennsylvania, United States, 18249
        • Galderma Investigational Site (Site 8754)
    • 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, 78660-3519
        • Galderma Investigational Site (Site 8546)
    • Utah
      • Saint George, Utah, United States, 84790
        • Galderma Investigational Site (Site 8776)
      • Salt Lake City, Utah, United States, 84117
        • Galderma Investigational Site (Site 8672)
      • West Jordan, Utah, United States, 84101
        • Galderma Investigational Site (Site 8761)
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Galderma Investigational Site (Site 8057)
    • Washington
      • Burien, Washington, United States, 98168
        • Galderma Investigational Site (Site 8779)
      • Spokane, Washington, United States, 99202
        • Galderma Investigational Site (Site 8039)
      • Spokane, Washington, United States, 99202
        • Galderma Investigational Site (Site 8760)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MAL 16.8% Cream
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.
Drug: MAL 16.8% cream
Day light photodynamic therapy with MAL 16.8% cream
Other Names:
  • CD06809-41
PLACEBO_COMPARATOR: MAL Vehicle Cream
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.
Drug: MAL Vehicle Cream
Day light photodynamic therapy with MAL vehicle cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Response at Week 12
Time Frame: Week 12
Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lesion Complete Response at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12
Percentage of Participants With Partial Response at Week 12
Time Frame: 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.
Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD.06.SPR.112199

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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