Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp (NCT NCT05662202)
NCT ID: NCT05662202
Last Updated: 2026-08-21
Results Overview
Percentage of subjects with all AK target lesions clinically cleared after last PDT
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
12 weeks after the last PDT (Visit 4 or Visit 6)
Results posted on
2026-08-21
Participant Flow
Participant milestones
| Measure |
BF-200 ALA
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
Vehicle
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
36
|
|
Overall Study
COMPLETED
|
119
|
31
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
Reasons for withdrawal
| Measure |
BF-200 ALA
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
Vehicle
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Sponsor Request
|
1
|
1
|
|
Overall Study
Forbidden Medication/Procedure
|
2
|
1
|
|
Overall Study
Inability to Return for Visits
|
2
|
0
|
|
Overall Study
Noncompliance with Study Schedule
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
Baseline characteristics by cohort
| Measure |
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Number of Participants Analyzed · 18 - 64 years
|
41 Participants
n=5 Participants
|
10 Participants
n=109 Participants
|
51 Participants
n=133 Participants
|
|
Age, Customized
Number of Participants Analyzed · 65 - 74 years
|
60 Participants
n=5 Participants
|
21 Participants
n=109 Participants
|
81 Participants
n=133 Participants
|
|
Age, Customized
Number of Participants Analyzed · 75 years and older
|
35 Participants
n=5 Participants
|
5 Participants
n=109 Participants
|
40 Participants
n=133 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
20 Participants
n=109 Participants
|
80 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
16 Participants
n=109 Participants
|
92 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=5 Participants
|
36 Participants
n=109 Participants
|
172 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
36 Participants
n=109 Participants
|
171 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Fitzpatrick Skin Type, Categorical
Type I - III
|
131 Participants
n=5 Participants
|
33 Participants
n=109 Participants
|
164 Participants
n=133 Participants
|
|
Fitzpatrick Skin Type, Categorical
Type IV - VI
|
5 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
8 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last PDT (Visit 4 or Visit 6)Percentage of subjects with all AK target lesions clinically cleared after last PDT
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Overall Subject Complete Response Rate
|
6 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (Visit 4 or Visit 6)Population: This outcome measure only considers participants with lesions on the extremities.
Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT
Outcome measures
| Measure |
Vehicle
n=27 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=109 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Extremities
|
3 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (Visit 4 or Visit 6)Population: This outcome measure only considers participants treated on neck/trunk.
Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT
Outcome measures
| Measure |
Vehicle
n=9 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=27 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Neck/Trunk
|
3 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (Visit 4 or Visit 6)Population: The number of lesions analyzed differs in the rows, as these refer to different groups/subgroups.
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen).
Outcome measures
| Measure |
Vehicle
n=306 Lesions
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=1240 Lesions
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Lesion Complete Response Rate
By Treatment Area: Neck/Trunk
|
22 Lesions
|
207 Lesions
|
|
Lesion Complete Response Rate
Overall
|
121 Lesions
|
907 Lesions
|
|
Lesion Complete Response Rate
By Treatment Area: Extremities
|
99 Lesions
|
700 Lesions
|
|
Lesion Complete Response Rate
By AK Severity at Baseline: Mild
|
71 Lesions
|
604 Lesions
|
|
Lesion Complete Response Rate
By AK Severity at Baseline: Moderate
|
50 Lesions
|
303 Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (Visit 4 or Visit 6)Population: This outcome measure only considers participants with severe lesions. The number of lesions analyzed differs in the rows, as these refer to different groups/subgroups.
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area.
Outcome measures
| Measure |
Vehicle
n=1 Severe Lesions
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=5 Severe Lesions
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Complete Response Rate for Severe Lesions
Overall
|
0 Severe Lesions
|
2 Severe Lesions
|
|
Complete Response Rate for Severe Lesions
By Treatment Area: Extremities
|
0 Severe Lesions
|
2 Severe Lesions
|
|
Complete Response Rate for Severe Lesions
By Treatment Area: Neck/Trunk
|
0 Severe Lesions
|
0 Severe Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1 (Visit 4)Population: Analysis populations of the rows differ as these refer to different subpopulations of the overall population.
Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Subject Complete Response Rate After PDT-1
By Treatment Area: Extremities
|
2 Participants
|
18 Participants
|
|
Subject Complete Response Rate After PDT-1
By Treatment Area: Neck/Trunk
|
2 Participants
|
17 Participants
|
|
Subject Complete Response Rate After PDT-1
By Size of Treatment Field: 240 cm²
|
1 Participants
|
9 Participants
|
|
Subject Complete Response Rate After PDT-1
Overall
|
4 Participants
|
35 Participants
|
|
Subject Complete Response Rate After PDT-1
By Number of AK Target Lesions: 4 - 7
|
2 Participants
|
17 Participants
|
|
Subject Complete Response Rate After PDT-1
By Number of AK Target Lesions: 8 - 11
|
2 Participants
|
10 Participants
|
|
Subject Complete Response Rate After PDT-1
By Number of AK Target Lesions: 12 - 15
|
0 Participants
|
8 Participants
|
|
Subject Complete Response Rate After PDT-1
By Size of Treatment Field: 80 cm²
|
0 Participants
|
9 Participants
|
|
Subject Complete Response Rate After PDT-1
By Size of Treatment Field: 160 cm²
|
3 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1 (Visit 4)Population: The number of lesions analyzed differs in the rows, as these refer to different groups/subgroups.
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen \[mild, moderate, severe\]).
Outcome measures
| Measure |
Vehicle
n=306 Number of Lesions
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=1240 Number of Lesions
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Lesion Complete Response Rate After PDT-1
Overall
|
89 Number of Lesions
|
783 Number of Lesions
|
|
Lesion Complete Response Rate After PDT-1
By Treatment Area: Extremities
|
74 Number of Lesions
|
584 Number of Lesions
|
|
Lesion Complete Response Rate After PDT-1
By Treatment Area: Neck/Trunk
|
15 Number of Lesions
|
199 Number of Lesions
|
|
Lesion Complete Response Rate After PDT-1
By AK Severity at Baseline: Mild
|
59 Number of Lesions
|
522 Number of Lesions
|
|
Lesion Complete Response Rate After PDT-1
By AK Severity at Baseline: Moderate
|
30 Number of Lesions
|
261 Number of Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1 (Visit 4)Population: This outcome measure only considers participants with severe lesions. The number of lesions analyzed differs in the rows, as these refer to different groups/subgroups.
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen \[mild, moderate, severe\]; Visit 2) after PDT-1, overall and stratified by treatment area.
Outcome measures
| Measure |
Vehicle
n=1 Number of Severe Lesions
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=5 Number of Severe Lesions
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Complete Response Rate for Severe Lesions After PDT-1
Overall
|
0 Number of Severe Lesions
|
1 Number of Severe Lesions
|
|
Complete Response Rate for Severe Lesions After PDT-1
By Treatment Area: Extremities
|
0 Number of Severe Lesions
|
1 Number of Severe Lesions
|
|
Complete Response Rate for Severe Lesions After PDT-1
By Treatment Area: Neck/Trunk
|
0 Number of Severe Lesions
|
0 Number of Severe Lesions
|
SECONDARY outcome
Timeframe: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)Population: In some cases, the assessment was inadvertently missed or subjects withdrew from the study before the assessment. Analysis populations of the rows differ as these refer to different subpopulations of the overall population.
The esthetic appearance after the last PDT as assessed by the investigator according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
Outcome measures
| Measure |
Vehicle
n=31 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=117 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
Overall · Very Good
|
11 Participants
|
67 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
Overall · Good
|
6 Participants
|
21 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
Overall · Satisfactory
|
5 Participants
|
25 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
Overall · Unsatisfactory
|
9 Participants
|
4 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Extremities · Very Good
|
7 Participants
|
48 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Extremities · Good
|
6 Participants
|
17 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Extremities · Satisfactory
|
5 Participants
|
23 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Extremities · Unsatisfactory
|
6 Participants
|
4 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Neck/Trunk · Very Good
|
4 Participants
|
19 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Neck/Trunk · Good
|
0 Participants
|
4 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Neck/Trunk · Satisfactory
|
0 Participants
|
2 Participants
|
|
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
By Treatment Area: Neck/Trunk · Unsatisfactory
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)Population: In some cases, the assessment was inadvertently missed or subjects withdrew from the study before the assessment. Analysis populations of the rows differ as these refer to different subpopulations of the overall population.
The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
Outcome measures
| Measure |
Vehicle
n=31 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=117 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
Overall · Very Good
|
7 Participants
|
53 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
Overall · Good
|
8 Participants
|
30 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
Overall · Satisfactory
|
5 Participants
|
26 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
Overall · Unsatisfactory
|
11 Participants
|
8 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Extremities · Very Good
|
3 Participants
|
41 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Extremities · Good
|
7 Participants
|
21 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Extremities · Satisfactory
|
5 Participants
|
22 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Extremities · Unsatisfactory
|
9 Participants
|
8 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Neck/Trunk · Very Good
|
4 Participants
|
12 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Neck/Trunk · Good
|
1 Participants
|
9 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Neck/Trunk · Satisfactory
|
0 Participants
|
4 Participants
|
|
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
By Treatment Area: Neck/Trunk · Unsatisfactory
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)Population: In some cases, the assessment was inadvertently missed or subjects withdrew from the study before the assessment. Analysis populations of the rows differ as these refer to different subpopulations of the overall population.
Satisfaction with PDT treatment after the last PDT as assessed by the subject; overall and stratified by treatment area. Therefore, subjects were asked if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no).
Outcome measures
| Measure |
Vehicle
n=30 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=117 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Satisfaction With PDT at the End of Treatment Phase
Overall · Subject would choose PDT again
|
26 Participants
|
101 Participants
|
|
Satisfaction With PDT at the End of Treatment Phase
Overall · Subject would not choose PDT again
|
4 Participants
|
16 Participants
|
|
Satisfaction With PDT at the End of Treatment Phase
By Treatment Area: Extremities · Subject would choose PDT again
|
19 Participants
|
80 Participants
|
|
Satisfaction With PDT at the End of Treatment Phase
By Treatment Area: Extremities · Subject would not choose PDT again
|
4 Participants
|
12 Participants
|
|
Satisfaction With PDT at the End of Treatment Phase
By Treatment Area: Neck/Trunk · Subject would choose PDT again
|
7 Participants
|
21 Participants
|
|
Satisfaction With PDT at the End of Treatment Phase
By Treatment Area: Neck/Trunk · Subject would not choose PDT again
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)Population: Analysis populations of the rows may differ as these refer to different subpopulations of the overall population.
Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area. TEAEs were defined as all AEs starting with or after IMP application and within 12 weeks (+ 7 days) after the last PDT, or as related AEs (possibly, probably, or definitely related, or with missing relationship) occurring more than 12 weeks after the last PDT.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
AEs
|
25 Participants
|
132 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
AESIs
|
0 Participants
|
0 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
SAEs
|
4 Participants
|
12 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs
|
25 Participants
|
131 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By age group: 18 - 64 years
|
5 Participants
|
41 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By age group: 65 - 74 years
|
15 Participants
|
57 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By age group: 75 years and older
|
5 Participants
|
33 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By sex: female
|
16 Participants
|
59 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By sex: male
|
9 Participants
|
72 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By Fitzpatrick skin type: Type I - III
|
23 Participants
|
126 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By Fitzpatrick skin type: Type IV - VI
|
2 Participants
|
5 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By Size of treatment field: 80 cm²
|
5 Participants
|
34 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By Size of treatment field: 160 cm²
|
12 Participants
|
50 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By Size of treatment field: 240 cm²
|
8 Participants
|
47 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By treatment area: Extremities
|
18 Participants
|
105 Participants
|
|
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
TEAEs - By treatment area: Neck/trunk
|
7 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)New lesions: AK, non-melanoma skin cancer \[NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)\] or melanoma
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
New Lesions Inside the Treatment Field During Treatment Phase
|
6 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: All visits (except screening, Visit 1) throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)Population: The analysis population of the rows differ, as the assessment was added after study start with an amendment of the protocol.
Application site reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) were assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe. The worst severity across all assessment timepoints and illumination areas is presented.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Assessment of Application Site Reactions
Hyperalgesia · None
|
33 Participants
|
101 Participants
|
|
Assessment of Application Site Reactions
Hyperalgesia · Mild
|
1 Participants
|
16 Participants
|
|
Assessment of Application Site Reactions
Burning · None
|
30 Participants
|
41 Participants
|
|
Assessment of Application Site Reactions
Burning · Mild
|
4 Participants
|
47 Participants
|
|
Assessment of Application Site Reactions
Burning · Moderate
|
0 Participants
|
34 Participants
|
|
Assessment of Application Site Reactions
Burning · Severe
|
0 Participants
|
8 Participants
|
|
Assessment of Application Site Reactions
Hyperalgesia · Moderate
|
0 Participants
|
12 Participants
|
|
Assessment of Application Site Reactions
Hyperalgesia · Severe
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Irritation · None
|
32 Participants
|
95 Participants
|
|
Assessment of Application Site Reactions
Irritation · Mild
|
2 Participants
|
21 Participants
|
|
Assessment of Application Site Reactions
Irritation · Moderate
|
0 Participants
|
11 Participants
|
|
Assessment of Application Site Reactions
Irritation · Severe
|
0 Participants
|
3 Participants
|
|
Assessment of Application Site Reactions
Paraesthesia · None
|
31 Participants
|
84 Participants
|
|
Assessment of Application Site Reactions
Paraesthesia · Mild
|
3 Participants
|
32 Participants
|
|
Assessment of Application Site Reactions
Paraesthesia · Moderate
|
0 Participants
|
14 Participants
|
|
Assessment of Application Site Reactions
Paraesthesia · Severe
|
0 Participants
|
0 Participants
|
|
Assessment of Application Site Reactions
Pruritus · None
|
27 Participants
|
69 Participants
|
|
Assessment of Application Site Reactions
Pruritus · Mild
|
7 Participants
|
51 Participants
|
|
Assessment of Application Site Reactions
Pruritus · Moderate
|
0 Participants
|
9 Participants
|
|
Assessment of Application Site Reactions
Pruritus · Severe
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Bleeding · None
|
34 Participants
|
128 Participants
|
|
Assessment of Application Site Reactions
Bleeding · Mild
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Bleeding · Moderate
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Bleeding · Severe
|
0 Participants
|
0 Participants
|
|
Assessment of Application Site Reactions
Discharge · None
|
34 Participants
|
128 Participants
|
|
Assessment of Application Site Reactions
Discharge · Mild
|
0 Participants
|
2 Participants
|
|
Assessment of Application Site Reactions
Discharge · Moderate
|
0 Participants
|
0 Participants
|
|
Assessment of Application Site Reactions
Discharge · Severe
|
0 Participants
|
0 Participants
|
|
Assessment of Application Site Reactions
Edema · None
|
32 Participants
|
97 Participants
|
|
Assessment of Application Site Reactions
Edema · Mild
|
2 Participants
|
24 Participants
|
|
Assessment of Application Site Reactions
Edema · Moderate
|
0 Participants
|
9 Participants
|
|
Assessment of Application Site Reactions
Edema · Severe
|
0 Participants
|
0 Participants
|
|
Assessment of Application Site Reactions
Erosion · None
|
33 Participants
|
117 Participants
|
|
Assessment of Application Site Reactions
Erosion · Mild
|
1 Participants
|
8 Participants
|
|
Assessment of Application Site Reactions
Erosion · Moderate
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Erosion · Severe
|
0 Participants
|
4 Participants
|
|
Assessment of Application Site Reactions
Erythema · None
|
20 Participants
|
30 Participants
|
|
Assessment of Application Site Reactions
Erythema · Mild
|
12 Participants
|
46 Participants
|
|
Assessment of Application Site Reactions
Erythema · Moderate
|
2 Participants
|
42 Participants
|
|
Assessment of Application Site Reactions
Erythema · Severe
|
0 Participants
|
12 Participants
|
|
Assessment of Application Site Reactions
Exfoliation · None
|
33 Participants
|
102 Participants
|
|
Assessment of Application Site Reactions
Exfoliation · Mild
|
1 Participants
|
19 Participants
|
|
Assessment of Application Site Reactions
Exfoliation · Moderate
|
0 Participants
|
5 Participants
|
|
Assessment of Application Site Reactions
Exfoliation · Severe
|
0 Participants
|
4 Participants
|
|
Assessment of Application Site Reactions
Induration · None
|
34 Participants
|
105 Participants
|
|
Assessment of Application Site Reactions
Induration · Mild
|
0 Participants
|
17 Participants
|
|
Assessment of Application Site Reactions
Induration · Moderate
|
0 Participants
|
7 Participants
|
|
Assessment of Application Site Reactions
Induration · Severe
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Pustules · None
|
34 Participants
|
122 Participants
|
|
Assessment of Application Site Reactions
Pustules · Mild
|
0 Participants
|
5 Participants
|
|
Assessment of Application Site Reactions
Pustules · Moderate
|
0 Participants
|
2 Participants
|
|
Assessment of Application Site Reactions
Pustules · Severe
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Scabbing · None
|
33 Participants
|
96 Participants
|
|
Assessment of Application Site Reactions
Scabbing · Mild
|
1 Participants
|
29 Participants
|
|
Assessment of Application Site Reactions
Scabbing · Moderate
|
0 Participants
|
4 Participants
|
|
Assessment of Application Site Reactions
Scabbing · Severe
|
0 Participants
|
1 Participants
|
|
Assessment of Application Site Reactions
Vesicles · None
|
34 Participants
|
118 Participants
|
|
Assessment of Application Site Reactions
Vesicles · Mild
|
0 Participants
|
8 Participants
|
|
Assessment of Application Site Reactions
Vesicles · Moderate
|
0 Participants
|
3 Participants
|
|
Assessment of Application Site Reactions
Vesicles · Severe
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1)Population: Analysis populations of the rows differ as these refer to different subpopulations of the overall population.
Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area. The maximum of pain score over all illuminations is shown.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Application Site Pain During Illumination
By Treatment Area: Neck/Trunk
|
0.3 Pain score
Standard Deviation 0.5
|
5.8 Pain score
Standard Deviation 2.7
|
|
Application Site Pain During Illumination
Overall
|
0.4 Pain score
Standard Deviation 0.7
|
5.4 Pain score
Standard Deviation 2.5
|
|
Application Site Pain During Illumination
By Treatment Area: Extremities
|
0.4 Pain score
Standard Deviation 0.7
|
5.3 Pain score
Standard Deviation 2.4
|
|
Application Site Pain During Illumination
By Size of the Treatment Field: 80 cm²
|
0.1 Pain score
Standard Deviation 0.3
|
4.6 Pain score
Standard Deviation 2.2
|
|
Application Site Pain During Illumination
By Size of the Treatment Field: 160 cm²
|
0.4 Pain score
Standard Deviation 0.6
|
5.1 Pain score
Standard Deviation 2.2
|
|
Application Site Pain During Illumination
By Size of the Treatment Field: 240 cm²
|
0.5 Pain score
Standard Deviation 0.9
|
6.5 Pain score
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)Number of patients with changes in blood pressure (systolic and diastolic) \[mmHg\] and changes in pulse rate \[beats/min\]. Findings which differed from reference range and were considered clinically significant were to be reported.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Number of Patients With Significant Changes of Vital Signs
Befort treatment start · Clinically significant vital signs reported
|
0 Participants
|
2 Participants
|
|
Number of Patients With Significant Changes of Vital Signs
Befort treatment start · No clinically significant vital signs reported
|
36 Participants
|
134 Participants
|
|
Number of Patients With Significant Changes of Vital Signs
After treatment start · Clinically significant vital signs reported
|
0 Participants
|
0 Participants
|
|
Number of Patients With Significant Changes of Vital Signs
After treatment start · No clinically significant vital signs reported
|
36 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differed from reference range and were considered clinically significant were to be reported.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Number of Patients With Significant Changes in Safety Laboratory
Befort treatment start · Clinically significant safety laboratory results reported
|
1 Participants
|
1 Participants
|
|
Number of Patients With Significant Changes in Safety Laboratory
Befort treatment start · No clinically significant safety laboratory results reported
|
35 Participants
|
135 Participants
|
|
Number of Patients With Significant Changes in Safety Laboratory
After treatment start · Clinically significant safety laboratory results reported
|
0 Participants
|
1 Participants
|
|
Number of Patients With Significant Changes in Safety Laboratory
After treatment start · No clinically significant safety laboratory results reported
|
36 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status were to be performed. Abnormal findings considered clinically significant were to be reported.
Outcome measures
| Measure |
Vehicle
n=36 Participants
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
BF-200 ALA
n=136 Participants
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Number of Patients With Abnormal Findings in Physical Examination
Befort treatment start · Clinically significant physical examination findings reported
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Findings in Physical Examination
Befort treatment start · No clinically significant physical examination findings reported
|
36 Participants
|
135 Participants
|
|
Number of Patients With Abnormal Findings in Physical Examination
After treatment start · Clinically significant physical examination findings reported
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Findings in Physical Examination
After treatment start · No clinically significant physical examination findings reported
|
36 Participants
|
135 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)The percentage of subjects with all AK target lesions clinically cleared 12 weeks after the last PDT presenting with at least one recurrent lesion during follow-up, stratified by demographics, study sites, AK baseline parameters
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)The percentage of AK target lesions showing recurrence in follow-up in relation to total number of clinically cleared AK target lesions 12 weeks after last PDT; overall and stratified by treatment area and AK severity at baseline (according to Olsen \[mild, moderate, severe\])
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)The percentage of severe AK lesions (according to Olsen \[mild, moderate, severe\]) showing recurrence in follow-up in relation to total number of clinically cleared severe AK lesions 12 weeks after last PDT; overall and stratified by treatment area
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)Satisfaction with PDT treatment after the last PDT as assessed by the subject via questionnaire, 1. if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no) and 2. how they would rate the PDT treatment in comparison to other treatment modalities, if applicable (better than/ similar/ worse). The treatment modalities should be documented, if applicable); overall and stratified by treatment area
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up duration, approx. 40 weeksRelevant AEs include AEs or conditions affecting skin health in the treatment field which may impair proper assessment of the recurrence rate of the treated AK lesions, or other clinically relevant events at the investigator's discretion as well as any SAE that has occurred since the final visit of the treatment phase (Visit 4 or Visit 6); overall and stratified by demographics and treatment area
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)New lesions: AK, non-melanoma skin cancer \[NMSC, including BCC, SCC or BD\] or melanoma
Outcome measures
Outcome data not reported
Adverse Events
BF-200 ALA
Serious events: 12 serious events
Other events: 132 other events
Deaths: 0 deaths
Vehicle
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BF-200 ALA
n=136 participants at risk
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
Vehicle
n=36 participants at risk
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/136 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Investigations
Electrocardiogram abnormal
|
0.74%
1/136 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.2%
3/136 • Number of events 7 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
1/136 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/136 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/136 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.74%
1/136 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
2.2%
3/136 • Number of events 8 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
1.5%
2/136 • Number of events 2 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxoid liposarcoma
|
0.74%
1/136 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.74%
1/136 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.2%
3/136 • Number of events 3 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 2 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
Other adverse events
| Measure |
BF-200 ALA
n=136 participants at risk
Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).
Red light photodynamic therapy (PDT)
|
Vehicle
n=36 participants at risk
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
|
|---|---|---|
|
General disorders
Application site erosion
|
10.3%
14/136 • Number of events 15 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site erythema
|
80.9%
110/136 • Number of events 161 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
38.9%
14/36 • Number of events 21 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site exfoliation
|
27.9%
38/136 • Number of events 48 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site hyperaesthesia
|
22.1%
30/136 • Number of events 38 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site induration
|
18.4%
25/136 • Number of events 30 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site irritation
|
25.7%
35/136 • Number of events 39 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
5.6%
2/36 • Number of events 2 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site oedema
|
27.9%
38/136 • Number of events 44 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
5.6%
2/36 • Number of events 2 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site pain
|
73.5%
100/136 • Number of events 138 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
11.1%
4/36 • Number of events 4 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site paraesthesia
|
36.0%
49/136 • Number of events 63 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
8.3%
3/36 • Number of events 3 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site pruritus
|
53.7%
73/136 • Number of events 99 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
22.2%
8/36 • Number of events 8 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site scab
|
25.0%
34/136 • Number of events 40 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
2.8%
1/36 • Number of events 1 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
General disorders
Application site vesicles
|
12.5%
17/136 • Number of events 21 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Infections and infestations
Application site pustules
|
6.6%
9/136 • Number of events 11 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
0.00%
0/36 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
17.6%
24/136 • Number of events 38 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
13.9%
5/36 • Number of events 7 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/136 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
5.6%
2/36 • Number of events 2 • Collection of AEs started with signing the informed consent documents and ended with the end of the treatment phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the Study and results shall not be published in any form without prior consent of Sponsor. All decisions on the timing and content of publications/ presentations will be coordinated by Sponsor. A draft of any manuscript, talks, abstracts, and all similar material shall be submitted to sponsor at least sixty (60) days before submission of the final form to any journal, scientific conference, symposium, or program review committee prior to publication or other release.
- Publication restrictions are in place
Restriction type: OTHER