Keratosis, ActinicPhase 3NCT04269395

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

A Phase 3 study testing MAL Cream in people with Keratosis, Actinic, run by Galderma R&D at 53 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Keratosis, Actinic
What is being tested?: MAL Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 53 sitesin 2 countries
Study dates: 7 Apr 2020to 1 Sep 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 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

Who cannot join

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

Trial locations and contacts

53 sites in 2 countries.

Country

City, postcode or hospital

53 sites in 2 countries

United States52 sites

Galderma Investigational Site (Site#8759)
Albuquerque, New Mexico, 87102
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
Boise, Idaho, 83713
Galderma Investigational Site (Site#8479)
Bradenton, Florida, 34209
Galderma Investigational Site
Brooklyn, New York, 11209
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
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
Edina, Minnesota, 55410
Galderma Investigational Site (Site#8577)
Encinitas, California, 92024
Galderma Investigational Site (Site#8447)
Fort Smith, Arkansas, 72916
Galderma Investigational Site (Site#8636)
Fountain Valley, California, 92708
Galderma Investigational Site (Site#8224)
Fremont, California, 94538
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#8769)
Lake Worth, Florida, 33461
Galderma Investigational 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#8725)
Morgantown, West Virginia, 26505
Galderma Investigational Site (Site#8207)
Nashville, Tennessee, 37215
Galderma Investigational Site
New York, New York, 10010
Galderma Investigational Site
New York, New York, 10022
Galderma Investigational Site
New York, New York, 10029-6501
Galderma Investigational Site
New York, New York, 10075
Galderma Investigational Site (Site#8765)
North Miami Beach, Florida, 33162
Galderma Investigational Site (Site#8048)
Omaha, Nebraska, 68144
Galderma Investigational Site (Site#8734)
Pembroke Pines, Florida, 33028
Galderma Investigational Site (Site#8546)
Pflugerville, Texas, 78660
Galderma Investigational Site
Philadelphia, Pennsylvania, 19103
Galderma Investigational Site
Pittsburgh, Pennsylvania, 15213
Galderma Investigational Site (Site#8212)
Portland, Oregon, 97210
Galderma Investigational Site 9Site#8420)
Portsmouth, New Hampshire, 03801
Galderma Investigational Site (Site#8757)
Saint Joseph, Michigan, 49085
Galderma Investigational Site (Site#8761)
Salt Lake City, Utah, 84101
Galderma Investigational Site (Site#8672)
Salt Lake City, Utah, 84117
Galderma Investigational Site (Site#8529)
Sanford, Florida, 32771
Galderma Investigational Site (Site#8779)
Seattle, Washington, 98168
Galderma Investigational Site (Site#8760)
Spokane, Washington, 99202
Galderma Investigational Site 2(Site#8039)
Spokane, Washington, 99202
Galderma Investigational Site
St Louis, Missouri, 63141
Galderma Investigational Site (Site#8776)
St. George, Utah, 84790
Galderma Investigational Site
Sugarloaf, Pennsylvania, 18249
Galderma Investigational Site (Site#8126)
West Palm Beach, Florida, 33401

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 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.

Read the 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).

Conditions: Keratosis, Actinic
Being tested: MAL Cream, 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 CreamDrug
Also called CD06809-41
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.
Vehicle creamDrug
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.

Study groups in NCT04269395
Study group	Role	What they receive
MAL Cream Arm	Active comparator	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. Receives: Drug: MAL Cream
Vehicle Cream Arm	Placebo comparator	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. Receives: Drug: Vehicle cream

What is being measured

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

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.
Measured: At Week 54

Secondary outcomes (2)

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.
Measured: At Week 28 and Week 54
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.
Measured: At Week 28

Timeline

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

7 Apr 20201 Sep 2021

First posted13 Feb 2020
Study start7 Apr 2020
Primary completion1 Sep 2021
Study completion1 Sep 2021

Why it stopped: The study was terminated early as per Sponsor's decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04269395
Sponsor's protocol ID: RD.06.SPR.115230
Status last verified: Sep 2023
First submitted: 10 Feb 2020
Last updated: 10 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

All Keratosis, Actinic trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04269395
Acronym / sponsor ID: RD.06.SPR.115230
Conditions: Keratosis, Actinic
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated early as per Sponsor's decision
Enrolment: 125 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 7 Apr 2020 (actual)
Primary completion: 1 Sep 2021 (actual)
Study completion: 1 Sep 2021 (actual)
First posted: 13 Feb 2020 (actual)
Results: Posted 10 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MAL Cream Arm	Active comparator	Drug: MAL CreamParticipants 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.
Vehicle Cream Arm	Placebo comparator	Drug: Vehicle creamParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MAL CreamAlso: CD06809-41No 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.	Drug	MAL Cream Arm
Vehicle creamNo 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.	Drug	Vehicle Cream Arm

Primary outcome

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.

2 secondary outcomes

Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54
Time frame: 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

Results and safety

Results posted to the registry on 10 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MAL Cream Arm	87	73
Vehicle Cream Arm	38	28

Primary outcome: Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54

Time frame: At Week 54. Count of participants. Unit: Participants

Measure	MAL Cream Arm n = 75	Vehicle Cream Arm n = 30
Value	30	12

Population analysed: Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration up to Week 54. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAL Cream Arm	0 of 87 (0%)	22 of 87 (25.3%)	0 of 87
Vehicle Cream Arm	0 of 38 (0%)	11 of 38 (28.9%)	0 of 38

Limitations and caveats (from the sponsor): This LTFU study was terminated early by the Sponsor because in the main study RD.06.SPR.112199, the primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT in terms of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Keratosis, Actinic

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

53 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MAL Cream in people with Keratosis, Actinic, run by Galderma R&D at 53 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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 10 Oct 2023). 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?

Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 (time frame: At Week 54). 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 NCT04269395.

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 10 Oct 2023.