Trial · NCT04085367
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
NCT04085367, Phase 3, Completed, Galderma R&D; results first posted 2022-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04085367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04085367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT04085367
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 557 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Actinic Keratoses
- Interventions
- MAL 16.8% cream, MAL Vehicle Cream
- First posted
- 2019-09-11
- Last updated
- 2022-04-01
- Results first posted
- 2022-04-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response at Week 12 | 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 | Percent Change From Baseline in Lesion Complete Response at Week 12 | 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. |
| Secondary | Percentage of Participants With Partial Response at Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response at Week 12 | Week 12 | ITT analysis population included all participants randomized in the study. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Lesion Complete Response at Week 12 | Baseline, Week 12 | ITT analysis population included all participants randomized in the study. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Partial Response at Week 12 | Week 12 | ITT analysis population included all participants randomized in the study. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response at Week 12 | MAL 16.8% Cream | 25.3 | percentage of participants | ||
| Percentage of Participants With Complete Response at Week 12 | MAL Vehicle Cream | 23.0 | percentage of participants | ||
| Percent Change From Baseline in Lesion Complete Response at Week 12 | MAL 16.8% Cream | -61.1 | Standard Error 1.79 | percent change | |
| Percent Change From Baseline in Lesion Complete Response at Week 12 | MAL Vehicle Cream | -49.4 | Standard Error 2.45 | percent change | |
| Percentage of Participants With Partial Response at Week 12 | MAL 16.8% Cream | 48.2 | percentage of participants | ||
| Percentage of Participants With Partial Response at Week 12 | MAL Vehicle Cream | 35.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MAL 16.8% Cream | 364 | |
| Overall Study | STARTED | MAL Vehicle Cream | 193 | |
| Overall Study | COMPLETED | MAL 16.8% Cream | 344 | |
| Overall Study | COMPLETED | MAL Vehicle Cream | 185 | |
| Overall Study | NOT COMPLETED | MAL 16.8% Cream | 20 | |
| Overall Study | NOT COMPLETED | MAL Vehicle Cream | 8 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Actinic keratosis | Skin and subcutaneous tissue disorders | MAL 16.8% Cream | 62 | 364 | |
| other | Actinic keratosis | Skin and subcutaneous tissue disorders | MAL Vehicle Cream | 30 | 193 | |
| other | Skin lesion | Skin and subcutaneous tissue disorders | MAL 16.8% Cream | 4 | 364 | |
| other | Skin lesion | Skin and subcutaneous tissue disorders | MAL Vehicle Cream | 2 | 193 | |
| other | Application site pain | General disorders | MAL 16.8% Cream | 11 | 364 | |
| other | Application site pain | General disorders | MAL Vehicle Cream | 2 | 193 | |
| other | Application site erythema | General disorders | MAL 16.8% Cream | 12 | 364 | |
| other | Application site erythema | General disorders | MAL Vehicle Cream | 0 | 193 | |
| other | Application site dermatitis | General disorders | MAL 16.8% Cream | 7 | 364 | |
| other | Application site dermatitis | General disorders | MAL Vehicle Cream | 1 | 193 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MAL 16.8% Cream | 0 | 364 |
| Total, all-cause mortality | MAL Vehicle Cream | 0 | 193 |
| Total, other adverse events | MAL 16.8% Cream | 89 | 364 |
| Total, other adverse events | MAL Vehicle Cream | 41 | 193 |
| Total, serious adverse events | MAL 16.8% Cream | 5 | 364 |
| Total, serious adverse events | MAL Vehicle Cream | 1 | 193 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MAL 16.8% Cream vs MAL Vehicle Cream: deaths from any cause | Trial comparisons |
| MAL 16.8% Cream vs MAL Vehicle Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04085367
GET https://conductscience.org/api/trials/v1/NCT04085367/events?page=2