Trial Outcomes & Findings for 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 NCT04085367)
NCT ID: NCT04085367
Last Updated: 2022-04-01
Results Overview
Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
557 participants
Primary outcome timeframe
Week 12
Results posted on
2022-04-01
Participant Flow
A total of 557 participants were randomized in 2:1 ratio in two treatment group, MAL 16.8% cream and vehicle cream in study centers in the United States with diverse latitude, altitude, and climate characteristics.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
364
|
193
|
|
Overall Study
COMPLETED
|
344
|
185
|
|
Overall Study
NOT COMPLETED
|
20
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Other unspecified
|
2
|
1
|
|
Overall Study
Status Unknown
|
1
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
MAL 16.8% Cream
n=364 Participants
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.
|
MAL Vehicle Cream
n=193 Participants
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.
|
Total
n=557 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 9.00 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
266 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
327 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
504 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
359 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
551 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT analysis population included all participants randomized in the study.
Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Outcome measures
| Measure |
MAL 16.8% Cream
n=364 Participants
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. 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.
|
MAL Vehicle Cream
n=193 Participants
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. 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.
|
|---|---|---|
|
Percentage of Participants With Complete Response at Week 12
|
25.3 percentage of participants
|
23.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT analysis population included all participants randomized in the study.
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.
Outcome measures
| Measure |
MAL 16.8% Cream
n=364 Participants
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. 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.
|
MAL Vehicle Cream
n=193 Participants
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. 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.
|
|---|---|---|
|
Percent Change From Baseline in Lesion Complete Response at Week 12
|
-61.1 percent change
Standard Error 1.79
|
-49.4 percent change
Standard Error 2.45
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis population included all participants randomized in the study.
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.
Outcome measures
| Measure |
MAL 16.8% Cream
n=364 Participants
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. 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.
|
MAL Vehicle Cream
n=193 Participants
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. 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.
|
|---|---|---|
|
Percentage of Participants With Partial Response at Week 12
|
48.2 percentage of participants
|
35.1 percentage of participants
|
Adverse Events
MAL 16.8% Cream
Serious events: 5 serious events
Other events: 89 other events
Deaths: 0 deaths
MAL Vehicle Cream
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MAL 16.8% Cream
n=364 participants at risk
Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.
|
MAL Vehicle Cream
n=193 participants at risk
Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Back injury
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.52%
1/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Infections and infestations
Streptococcal endocarditis
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.27%
1/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
Other adverse events
| Measure |
MAL 16.8% Cream
n=364 participants at risk
Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.
|
MAL Vehicle Cream
n=193 participants at risk
Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
17.0%
62/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
15.5%
30/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.1%
4/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
1.0%
2/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
General disorders
Application site pain
|
3.0%
11/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
1.0%
2/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
General disorders
Application site erythema
|
3.3%
12/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.00%
0/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
General disorders
Application site dermatitis
|
1.9%
7/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
0.52%
1/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
General disorders
Application site pruritus
|
1.4%
5/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
1.6%
3/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.9%
7/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
1.6%
3/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
4/364 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
2.1%
4/193 • Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place