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Actinic KeratosesPhase 3NCT04085367

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

A Phase 3 study testing MAL 16.8% cream in people with Actinic Keratoses, run by Galderma R&D at 60 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratoses
What is being tested?
MAL 16.8% cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
557 participants
Where
60 sitesin 2 countries
Study dates
30 Sep 2019to 7 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

60 sites in 2 countries.

60 sites in 2 countries

United States59 sites

  • Galderma Investigational Site (Site 8759)

    Albuquerque, New Mexico, 87102

  • Galderma Investigational Site (Site 8683)

    Atlanta, Georgia, 30342-1418

  • Galderma Investigational Site (Site 8860)

    Atlanta, Georgia, 30342

  • Galderma Investigational Site (Site 8076)

    Austin, Texas, 78759

  • Galderma Investigational Site (Site 8208)

    Beverly, Massachusetts, 01915

  • Galderma Investigational Site (Site 8755)

    Boise, Idaho, 83704

  • Galderma Investigational Site (Site 8479)

    Bradenton, Florida, 34209

  • Galderma Investigational Site (Site 8242)

    Brooklyn, New York, 11203

  • Galderma Investigational Site (Site 8779)

    Burien, Washington, 98168

  • Galderma Investigational Site (Site 8777)

    Charleston, South Carolina, 29407

  • Galderma Investigational Site (Site 8566)

    Charlotte, North Carolina, 28277

  • Galderma Investigational Site (Site 8574)

    Clarkston, Michigan, 48346-3198

  • Galderma Investigational Site (Site 8139)

    College Station, Texas, 77845

  • Galderma Investigational Site (Site 8667)

    Columbus, Georgia, 31904

  • Galderma Investigational Site (Site 8838)

    Darien, Illinois, 60561

  • Galderma Investigational Site (Site 8778)

    Denver, Colorado, 80210

  • Galderma Investigational Site (Site 8595)

    Dublin, Ohio, 43016

  • Galderma Investigational Site (Site 8762)

    Edina, Minnesota, 55424-1200

  • Galderma Investigational Site (Site 8577)

    Encinitas, California, 92024

  • Galderma Investigational Site (Site 8447)

    Fort Smith, Arkansas, 72916-6103

  • Galderma Investigational Site (Site 8636)

    Fountain Valley, California, 92708

  • Galderma Investigational Site (Site 8224)

    Fremont, California, 94538

  • Galderma Investigational Site (Site 8114)

    Fresno, California, 93720

  • Galderma Investigational Site (Site 8664)

    Frisco, Texas, 75034

  • Galderma Investigational Site (Site 8440)

    Greenwood Village, Colorado, 80111

  • Galderma Investigational Site (Site # 8576)

    Houston, Texas, 77056

  • Galderma Investigational Site (Site 8770)

    Lehigh Acres, Florida, 33936

  • Galderma Investigational Site (Site 8724)

    Louisville, Kentucky, 40241

  • Galderma Investigational Site (Site 8057)

    Lynchburg, Virginia, 24501

  • Galderma Investigational Site (Site 8656)

    Miami, Florida, 33137

  • Galderma Investigational Site (Site 8725)

    Morgantown, West Virginia, 26505

  • Galderma Investigational Site (Site 8207)

    Nashville, Tennessee, 37215

  • Galderma Investigational Site (Site 8140)

    New Brighton, Minnesota, 55112

  • Galderma Investigational Site (Site 8733)

    New York, New York, 10022

  • Galderma Investigational Site (Site 8279)

    New York, New York, 10075

  • Galderma Investigational Site (Site 8765)

    North Miami Beach, Florida, 33162

  • Galderma Investigational Site (Site 8048)

    Omaha, Nebraska, 68144

  • Galderma Investigation Site (Site 8769)

    Palm Springs, Florida, 33461

  • Galderma Investigational Site (Site 8734)

    Pembroke Pines, Florida, 33028

  • Galderma Investigational Site (Site 8546)

    Pflugerville, Texas, 78660-3519

  • Galderma Investigational Site (Site 8255)

    Philadelphia, Pennsylvania, 19103

  • Galderma Investigational Site (Site 8721)

    Pittsburgh, Pennsylvania, 15213

  • Galderma Investiational Site (Site 8212)

    Portland, Oregon, 97210-2996

  • Galderma Investigational Site (Site 8420)

    Portsmouth, New Hampshire, 03801

  • Galderma Investigation Site (Site 8757)

    Saint Joseph, Michigan, 49085

  • Galderma Investigational Site (Site 8672)

    Salt Lake City, Utah, 84117

  • Galderma Investigational Site (Site 8758)

    San Diego, California, 92121

  • Galderma Investigational Site (Site 8529)

    Sanford, Florida, 32771

  • Galderma Investigational Site (Site 8608)

    Santa Monica, California, 90404

  • Galderma Investigational Site (Site 8039)

    Spokane, Washington, 99202

  • Galderma Investigational Site (Site 8760)

    Spokane, Washington, 99202

  • Galderma Investigational Site (Site 8219)

    St Louis, Missouri, 63141

  • Galderma Investigational Site (Site 8869)

    St Louis, Missouri, 63141

  • Galderma Investigational Site (Site 8776)

    St. George, Utah, 84790

  • Galderma Investigational Site (Site 8754)

    Sugarloaf, Pennsylvania, 18249

  • Galderma Investigational Site (Site 8768)

    Tucson, Arizona, 85718

  • Galderma Investigational Site (Site 8761)

    West Jordan, Utah, 84101

  • Galderma Investigational Site (Site 8126)

    West Palm Beach, Florida, 33401

  • Galderma Investigational Site (Site 8726)

    Wilmington, North Carolina, 28405-3176

Other trials in United States

Puerto Rico1 site

  • Galderma Investigational Site (Site 8231)

    Aibonito, 00705

Other trials in Puerto Rico

About this study

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)

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).

Read the 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.

Being tested
MAL 16.8% cream, MAL Vehicle Cream
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAL 16.8% creamDrug

    Also called CD06809-41

    Day light photodynamic therapy with MAL 16.8% cream

  • MAL Vehicle CreamDrug

    Day light photodynamic therapy with MAL vehicle cream

Study groups in NCT04085367
Study groupRoleWhat they receive
MAL 16.8% CreamExperimentalParticipants 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.
Receives: Drug: MAL 16.8% cream
MAL Vehicle CreamPlacebo comparatorParticipants 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.
Receives: Drug: MAL Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 12

Secondary outcomes (2)

  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start30 Sep 2019
  3. Primary completion3 Mar 2021
  4. Study completion7 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
557 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04085367
Sponsor's protocol ID
RD.06.SPR.112199
Status last verified
Mar 2022
First submitted
9 Sep 2019
Last updated
1 Apr 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MAL 16.8% cream in people with Actinic Keratoses, run by Galderma R&D at 60 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04085367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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