Trial Outcomes & Findings for Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy (NCT NCT02144077)
NCT ID: NCT02144077
Last Updated: 2022-11-03
Results Overview
Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
281 participants
Primary outcome timeframe
12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Results posted on
2022-11-03
Participant Flow
Trial was conducted in Germany and United Kingdom with a total of 24 sites who recruited patients. Enrollment of patients started (first patient enrolled) 28-Jan-2014.
Of the 394 patients screened in this study, 281 patients were randomized (138 patients to BF-200 ALA and 143 patients to methyl-aminolevulinate) and treated. 113 patients were excluded before randomization due to screening failure (104 patients), patient's decision (7 patients), and lost to FU and "other reason" (each 1 patient).
Participant milestones
| Measure |
BF-200 ALA
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
143
|
|
Overall Study
COMPLETED
|
128
|
132
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
BF-200 ALA
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
no visits 7 & 8/no visits after visit 4
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy
Baseline characteristics by cohort
| Measure |
BF-200 ALA
n=138 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=143 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
86 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.
Outcome measures
| Measure |
BF-200 ALA
n=121 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=110 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT
|
93.4 Percentage of Patients
Interval 87.0 to 96.9
|
91.8 Percentage of Patients
Interval 84.6 to 96.0
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint.
Outcome measures
| Measure |
BF-200 ALA
n=148 individual lesions
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=127 individual lesions
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Lesion Complete Response Assessed 12 Weeks After the Last PDT
|
94.6 Percentage of Individual Lesions
Interval 89.3 to 97.5
|
92.9 Percentage of Individual Lesions
Interval 86.6 to 96.5
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint. Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris).
Outcome measures
| Measure |
BF-200 ALA
n=121 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=110 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline
|
-94.5 Percentage of Change
Standard Deviation 35.07
|
-97.0 Percentage of Change
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: 12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint.
Outcome measures
| Measure |
BF-200 ALA
n=121 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=110 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Patient Complete Response 12 Weeks After PDT-2
|
57.9 Percentage of Patients
Interval 48.5 to 66.7
|
56.4 Percentage of Patients
Interval 46.6 to 65.7
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline
Outcome measures
| Measure |
BF-200 ALA
n=120 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=109 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
Very good
|
23.3 Percentage of Patients
Interval 16.3 to 32.1
|
14.7 Percentage of Patients
Interval 8.9 to 23.0
|
|
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
Good
|
11.7 Percentage of Patients
Interval 6.8 to 19.1
|
18.3 Percentage of Patients
Interval 11.8 to 27.2
|
|
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
Satisfactory
|
35.8 Percentage of Patients
Interval 27.4 to 45.2
|
29.4 Percentage of Patients
Interval 21.2 to 39.0
|
|
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
Unsatisfactory
|
14.2 Percentage of Patients
Interval 8.7 to 22.0
|
20.2 Percentage of Patients
Interval 13.3 to 29.2
|
|
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
Impaired
|
15.0 Percentage of Patients
Interval 9.4 to 22.9
|
17.4 Percentage of Patients
Interval 11.1 to 26.1
|
SECONDARY outcome
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline
Outcome measures
| Measure |
BF-200 ALA
n=70 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=74 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
Very good
|
40.0 Percentage of Patients
Interval 28.7 to 52.4
|
21.6 Percentage of Patients
Interval 13.2 to 33.0
|
|
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
Good
|
20.0 Percentage of Patients
Interval 11.7 to 31.6
|
27.0 Percentage of Patients
Interval 17.7 to 38.8
|
|
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
Satisfactory
|
22.9 Percentage of Patients
Interval 14.0 to 34.7
|
32.4 Percentage of Patients
Interval 22.3 to 44.4
|
|
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
Unsatisfactory
|
11.4 Percentage of Patients
Interval 5.4 to 21.8
|
12.2 Percentage of Patients
Interval 6.1 to 22.3
|
|
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
Impaired
|
5.7 Percentage of Patients
Interval 1.8 to 14.7
|
6.8 Percentage of Patients
Interval 2.5 to 15.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 24, 36 and 60 months post-PDTPopulation: Per protocol analysis set in the follow-up (PPS-FUP): all patients of the full analysis set in the follow-up (FAS-UP) without any major protocol deviations
Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT
Outcome measures
| Measure |
BF-200 ALA
n=83 Participants
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=71 Participants
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Patient Recurrence Rate (Overall, Cumulative)
|
16.9 percentage of patients (cumulative)
|
15.5 percentage of patients (cumulative)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, 24, 36 and 60 months post-PDTPopulation: Per protocol analysis in follow-up (PPS-FUP): All lesions in patients in the full analysis set in follow-up (FAS-FUP) without any major protocol deviations
Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)).
Outcome measures
| Measure |
BF-200 ALA
n=104 Lesions
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=82 Lesions
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Lesion Recurrence Rate (Cumulative)
Overall
|
13.5 percentage of lesions (cumulative)
|
13.4 percentage of lesions (cumulative)
|
|
Lesion Recurrence Rate (Cumulative)
sBCC
|
10.3 percentage of lesions (cumulative)
|
11.9 percentage of lesions (cumulative)
|
|
Lesion Recurrence Rate (Cumulative)
nBCC
|
25 percentage of lesions (cumulative)
|
21.4 percentage of lesions (cumulative)
|
Adverse Events
BF-200 ALA
Serious events: 3 serious events
Other events: 138 other events
Deaths: 0 deaths
Methyl-aminolevulinate
Serious events: 7 serious events
Other events: 143 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BF-200 ALA
n=138 participants at risk
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=143 participants at risk
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
Cardiac disorders
Supraventricular trachycardia
|
0.72%
1/138 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.00%
0/143 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Eye disorders
Glaucoma
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Death
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.72%
1/138 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.00%
0/143 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.72%
1/138 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.00%
0/143 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/138 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
0.70%
1/143 • Number of events 1 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
Other adverse events
| Measure |
BF-200 ALA
n=138 participants at risk
Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
Methyl-aminolevulinate
n=143 participants at risk
Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU.
|
|---|---|---|
|
General disorders
Application site pain
|
97.1%
134/138 • Number of events 718 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
100.0%
143/143 • Number of events 751 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site erythema
|
87.0%
120/138 • Number of events 309 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
88.1%
126/143 • Number of events 288 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site pruritus
|
42.8%
59/138 • Number of events 91 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
34.3%
49/143 • Number of events 84 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site oedema
|
30.4%
42/138 • Number of events 86 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
36.4%
52/143 • Number of events 108 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site paraesthesia
|
29.0%
40/138 • Number of events 64 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
27.3%
39/143 • Number of events 65 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site scab
|
24.6%
34/138 • Number of events 45 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
28.7%
41/143 • Number of events 49 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site induration
|
23.2%
32/138 • Number of events 63 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
18.9%
27/143 • Number of events 50 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site discharge
|
17.4%
24/138 • Number of events 38 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
16.8%
24/143 • Number of events 32 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site exfoliation
|
15.9%
22/138 • Number of events 25 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
8.4%
12/143 • Number of events 13 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site erosion
|
13.0%
18/138 • Number of events 22 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
6.3%
9/143 • Number of events 10 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site vesicles
|
7.2%
10/138 • Number of events 13 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
7.7%
11/143 • Number of events 13 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
General disorders
Application site discolouration
|
2.9%
4/138 • Number of events 4 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
5.6%
8/143 • Number of events 10 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
3.6%
5/138 • Number of events 5 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
6.3%
9/143 • Number of events 11 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
11/138 • Number of events 13 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
7.0%
10/143 • Number of events 10 • Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
|
Additional Information
Clinical Trial Department
Biofrontera Bioscience GmbH
Phone: +49 214 876 32 66
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor will review results communications prior to public release and has to approve in order to ensure the adequate reporting of study results. The sponsor can't refuse publication for unfair reasons.
- Publication restrictions are in place
Restriction type: OTHER