Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT). (NCT NCT03573401)
NCT ID: NCT03573401
Last Updated: 2026-01-14
Results Overview
Each subject had one Main Target Lesion. The composite clinical and histological response rate of the subjects' Main Target Lesions is the percentage of subjects with a clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
187 participants
Primary outcome timeframe
12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion
Results posted on
2026-01-14
Participant Flow
Of 281 subjects assessed for eligibility, 187 subjects met the inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
BF-200 ALA
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
42
|
|
Overall Study
COMPLETED
|
141
|
41
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
BF-200 ALA
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Subject non-compliance with study schedule
|
1
|
0
|
|
Overall Study
Discontinuation of study treatment due to subject decision
|
1
|
0
|
|
Overall Study
Subject required prohibited medication for concomitant medical condition
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
Baseline characteristics by cohort
| Measure |
BF-200 ALA
n=145 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=14 Participants
|
15 Participants
n=10 Participants
|
96 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
64 Participants
n=14 Participants
|
27 Participants
n=10 Participants
|
91 Participants
n=24 Participants
|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 10.8 • n=14 Participants
|
66.1 years
STANDARD_DEVIATION 9.8 • n=10 Participants
|
63.2 years
STANDARD_DEVIATION 10.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=14 Participants
|
11 Participants
n=10 Participants
|
78 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=14 Participants
|
31 Participants
n=10 Participants
|
109 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=14 Participants
|
42 Participants
n=10 Participants
|
184 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=14 Participants
|
42 Participants
n=10 Participants
|
187 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Fitzpatrick Skin Type
I - III
|
138 Participants
n=14 Participants
|
40 Participants
n=10 Participants
|
178 Participants
n=24 Participants
|
|
Fitzpatrick Skin Type
IV - VI
|
7 Participants
n=14 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=24 Participants
|
|
Number of target lesions
1 target lesion
|
122 Participants
n=14 Participants
|
34 Participants
n=10 Participants
|
156 Participants
n=24 Participants
|
|
Number of target lesions
more than 1 target lesion
|
23 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
31 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the start of the last PDT cycle that included treatment of the Main Target LesionPopulation: Full analysis set
Each subject had one Main Target Lesion. The composite clinical and histological response rate of the subjects' Main Target Lesions is the percentage of subjects with a clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8).
Outcome measures
| Measure |
BF-200 ALA
n=145 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion.
|
65.5 percentage of subjects
|
4.8 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
1\. Key secondary endpoint: Percentage of Main Target Lesions with complete clinical clearance (i.e. according to clinical assessment only) 12 weeks after the start of the last PDT cycle.
Outcome measures
| Measure |
BF-200 ALA
n=145 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle
|
83.4 percentage of Main Target Lesions
|
21.4 percentage of Main Target Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
2\. Key secondary endpoint: Percentage of Main Target Lesions with complete histological clearance (i.e. according to histological assessment only) 12 weeks after the start of the last PDT cycle.
Outcome measures
| Measure |
BF-200 ALA
n=145 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Main Target Lesion Histological Response Rate (According to Histological Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle
|
75.9 percentage of Main Target Lesions
|
19.0 percentage of Main Target Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
3\. Key secondary endpoint: Percentage of subjects with complete clinical clearance of all Target Lesions (i.e. according to clinical assessment only) 12 weeks after the start of the last PDT cycle.
Outcome measures
| Measure |
BF-200 ALA
n=145 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle.
|
82.1 percentage of subjects
|
21.4 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
4\. Key secondary endpoint: Percentage of subjects with complete clinical and histological clearance of the Main Target Lesion and complete clinical clearance of all Additional Target Lesions 12 weeks after the start of the last PDT cycle
Outcome measures
| Measure |
BF-200 ALA
n=145 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After the Start of the Last PDT Cycle.
|
64.1 percentage of subjects
|
4.8 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
Further secondary endpoint: Percentage of Individual Target Lesions that are completely clinically cleared per treatment arm 12 weeks after the start of the last PDT cycle.
Outcome measures
| Measure |
BF-200 ALA
n=172 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=51 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After the Start of the Last PDT Cycle.
|
82.6 percentage of target lesions
|
21.6 percentage of target lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1Population: Full analysis set
Further secondary endpoint: Percentage of Main Target Lesions that are clinically and histologically cleared 12 weeks after PDT-1.
Outcome measures
| Measure |
BF-200 ALA
n=145 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Main Target Lesion Complete Response (Clinically and Histologically Cleared) Assessed 12 Weeks After PDT-1.
|
44.1 percentage of Main Target Lesions
|
2.4 percentage of Main Target Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1Population: Full analysis set
Further secondary endpoint: Percentage of Main Target Lesions that are clinically cleared 12 weeks after PDT-1.
Outcome measures
| Measure |
BF-200 ALA
n=145 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Main Target Lesion Clinical Response (According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1.
|
57.2 percentage of Main Target Lesions
|
14.3 percentage of Main Target Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1Population: Full analysis set
Further secondary endpoint: Percentage of Main Target Lesions that are histologically cleared 12 weeks after PDT-1.
Outcome measures
| Measure |
BF-200 ALA
n=145 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Number of Main Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Main Target Lesion Histological Response (According to Histological Assessment Only) Assessed 12 Weeks After PDT-1.
|
44.8 percentage of Main Target Lesions
|
2.4 percentage of Main Target Lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1Population: Full analysis set
Further secondary endpoint: Percentage of Individual Target Lesions that are completely clinically cleared per treatment arm 12 weeks after PDT-1
Outcome measures
| Measure |
BF-200 ALA
n=172 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=51 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After PDT-1.
|
58.7 percentage of target lesions
|
13.7 percentage of target lesions
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1Population: Full analysis set
Further secondary endpoint: Percentage of subjects with complete clinical clearance 12 weeks after PDT-1.
Outcome measures
| Measure |
BF-200 ALA
n=145 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1.
|
54.5 percentage of subjects
|
14.3 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-1Population: Full analysis set
Further secondary endpoint: Percentage of subjects with complete clinical and histological clearance of the Main Target Lesion and complete clinical clearance of Additional Target Lesions 12 weeks after PDT-1.
Outcome measures
| Measure |
BF-200 ALA
n=145 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 Participants
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After PDT-1..
|
41.4 percentage of subjects
|
2.4 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
Further secondary endpoint: Investigators assessment of the esthetic appearance of all Target lesions but prior to surgical excision of the Main Target Lesion or alternative Treatment of Additional Target Lesions
Outcome measures
| Measure |
BF-200 ALA
n=168 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=50 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
Very good
|
61.9 percentage of target lesions
|
34.0 percentage of target lesions
|
|
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
Good
|
27.4 percentage of target lesions
|
24.0 percentage of target lesions
|
|
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
Satisfactory
|
9.5 percentage of target lesions
|
28.0 percentage of target lesions
|
|
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
Unsatisfactory
|
0.6 percentage of target lesions
|
10.0 percentage of target lesions
|
|
For All Target Lesions, Assessment of Esthetic Appearance by the Investigator 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion and Any Alternative Treatment of Additional Target Lesions.
No answer
|
0.6 percentage of target lesions
|
4.0 percentage of target lesions
|
SECONDARY outcome
Timeframe: 12 weeks after the start of the last PDT cyclePopulation: Full analysis set
Further secondary endpoint: Subject's assessment regarding the esthetic outcome and the Treatment 12 weeeks after the start of the last PDT cycle but prior to surgical excision of the Main Target Lesion or alternative Treatment of Additional Target Lesions
Outcome measures
| Measure |
BF-200 ALA
n=168 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=50 Number of Target Lesions
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
Very good
|
65.5 percentage of target lesions
|
56.0 percentage of target lesions
|
|
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
Good
|
22.6 percentage of target lesions
|
18.0 percentage of target lesions
|
|
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
Satisfactory
|
10.7 percentage of target lesions
|
8.0 percentage of target lesions
|
|
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
Unsatisfactory
|
0.6 percentage of target lesions
|
10.0 percentage of target lesions
|
|
Subjects' Satisfaction Regarding Esthetic Outcome and Treatment 12 Weeks After the Start of the Last PDT Cycle, But Prior to Surgical Excision of the Main Target Lesion or Alternative Treatment of Additional Target Lesions
No answer
|
0.6 percentage of target lesions
|
8.0 percentage of target lesions
|
Adverse Events
BF-200 ALA
Serious events: 3 serious events
Other events: 145 other events
Deaths: 0 deaths
Vehicle
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BF-200 ALA
n=145 participants at risk
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 participants at risk
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
Cardiac disorders
Sinus node dysfunction
|
0.69%
1/145 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
0.00%
0/42 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Infections and infestations
Atypical pneumonia
|
0.69%
1/145 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
0.00%
0/42 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/145 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
2.4%
1/42 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.69%
1/145 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
0.00%
0/42 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/145 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
2.4%
1/42 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
Other adverse events
| Measure |
BF-200 ALA
n=145 participants at risk
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
|
Vehicle
n=42 participants at risk
Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA.
|
|---|---|---|
|
General disorders
Application site discharge
|
2.8%
4/145 • Number of events 6 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
4.8%
2/42 • Number of events 2 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site discolouration
|
9.0%
13/145 • Number of events 15 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
2.4%
1/42 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site erosion
|
4.8%
7/145 • Number of events 8 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
7.1%
3/42 • Number of events 6 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site erythema
|
69.0%
100/145 • Number of events 228 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
38.1%
16/42 • Number of events 48 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site exfoliation
|
17.2%
25/145 • Number of events 30 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
16.7%
7/42 • Number of events 13 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site induration
|
17.2%
25/145 • Number of events 39 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
7.1%
3/42 • Number of events 3 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site oedema
|
29.0%
42/145 • Number of events 72 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
11.9%
5/42 • Number of events 10 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site pain
|
95.2%
138/145 • Number of events 785 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
28.6%
12/42 • Number of events 24 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site paraesthesia
|
24.1%
35/145 • Number of events 65 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
11.9%
5/42 • Number of events 8 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site pruritus
|
50.3%
73/145 • Number of events 176 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
26.2%
11/42 • Number of events 14 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site scab
|
22.1%
32/145 • Number of events 42 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
4.8%
2/42 • Number of events 2 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site ulcer
|
2.8%
4/145 • Number of events 4 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
2.4%
1/42 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site vesicles
|
8.3%
12/145 • Number of events 12 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
2.4%
1/42 • Number of events 1 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
General disorders
Application site warmth
|
2.1%
3/145 • Number of events 3 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
7.1%
3/42 • Number of events 3 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
2/145 • Number of events 2 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
4.8%
2/42 • Number of events 2 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.6%
11/145 • Number of events 16 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
9.5%
4/42 • Number of events 7 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.1%
3/145 • Number of events 3 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
4.8%
2/42 • Number of events 2 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
3/145 • Number of events 3 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
4.8%
2/42 • Number of events 2 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
6.9%
10/145 • Number of events 19 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
11.9%
5/42 • Number of events 6 • The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
All AEs described in the following are treatment-emergent adverse events (TEAEs). TEAEs were defined as all AEs with time of onset on or after the time of treatment with the investigational medicinal product within 4 weeks (28 days) after each PDT cycle or AEs identified to be at least possibly related to IMP or medical device. If unclear due to incomplete start time/date of AE or PDT, AEs were assumed to be TEAEs.
|
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