Trial Outcomes & Findings for Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK) (NCT NCT04319159)
NCT ID: NCT04319159
Last Updated: 2021-11-11
Results Overview
Blood samples for ALA analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of ALA in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)
Results posted on
2021-11-11
Participant Flow
Trial was conducted at one site in the USA that recruited subjects. Recruitment of subjects started on 05 March 2020.
48 subjects were screened for eligibility which was within 2 weeks prior to PDT. 2 of 48 subjects were re-screened due to the COVID-19 implications. 13 subjects were excluded as screening failures and one subject withdrew informed consent before treatment. In total, 32 subjects were treated. In this single-arm study, all participants received identical active treatment. Study data were analyzed primarily overall and additionally according to strata.
Participant milestones
| Measure |
BF-200 ALA (Stratum Face/Scalp and Stratum Periphery)
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
BF-200 ALA (Stratum Face/Scalp and Stratum Periphery)
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|
|
Overall Study
Screening failure
|
13
|
|
Overall Study
Re-screening due to COVID-19 implications
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)
Baseline characteristics by cohort
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Fitzpatrick skin type
I
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Fitzpatrick skin type
II
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Fitzpatrick skin type
III
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Blood samples for ALA analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of ALA in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
0.5h
|
8.904 ng/mL
Standard Deviation 3.3502
|
10.21 ng/mL
Standard Deviation 5.2811
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
1h
|
12.45 ng/mL
Standard Deviation 3.1865
|
9.383 ng/mL
Standard Deviation 5.2972
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
1.5h
|
18.96 ng/mL
Standard Deviation 2.4231
|
10.15 ng/mL
Standard Deviation 4.3289
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
2h
|
18.02 ng/mL
Standard Deviation 2.7917
|
9.561 ng/mL
Standard Deviation 6.3130
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
2.5h
|
23.06 ng/mL
Standard Deviation 2.1768
|
6.233 ng/mL
Standard Deviation 5.7572
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
3h
|
24.71 ng/mL
Standard Deviation 2.2076
|
13.55 ng/mL
Standard Deviation 5.3204
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
3.5h
|
22.00 ng/mL
Standard Deviation 1.9477
|
10.77 ng/mL
Standard Deviation 3.3921
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
4h
|
16.54 ng/mL
Standard Deviation 1.7954
|
7.172 ng/mL
Standard Deviation 3.4656
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
5h
|
10.21 ng/mL
Standard Deviation 1.6002
|
4.558 ng/mL
Standard Deviation 2.1024
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
6h
|
5.812 ng/mL
Standard Deviation 2.2470
|
4.231 ng/mL
Standard Deviation 1.9599
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
8h
|
3.250 ng/mL
Standard Deviation 2.0091
|
2.871 ng/mL
Standard Deviation 1.9438
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
10h
|
2.536 ng/mL
Standard Deviation 2.0871
|
3.444 ng/mL
Standard Deviation 1.8003
|
PRIMARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Blood samples for PpIX analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of PpIX in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.
Outcome measures
| Measure |
Stratum: Face/Scalp
n=15 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=15 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
0.5h
|
0.2820 ng/mL
Standard Deviation 2.2288
|
0.2199 ng/mL
Standard Deviation 3.7060
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
1h
|
0.3078 ng/mL
Standard Deviation 1.9993
|
0.1957 ng/mL
Standard Deviation 2.8664
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
1.5h
|
0.2176 ng/mL
Standard Deviation 2.8671
|
0.3022 ng/mL
Standard Deviation 1.7326
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
2h
|
0.1497 ng/mL
Standard Deviation 3.0551
|
0.2265 ng/mL
Standard Deviation 4.3780
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
2.5h
|
0.1634 ng/mL
Standard Deviation 2.2679
|
0.3389 ng/mL
Standard Deviation 1.8265
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
3h
|
0.1369 ng/mL
Standard Deviation 2.5145
|
0.1972 ng/mL
Standard Deviation 2.2296
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
3.5h
|
0.2313 ng/mL
Standard Deviation 1.5809
|
0.2334 ng/mL
Standard Deviation 3.4067
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
4h
|
0.2021 ng/mL
Standard Deviation 2.7651
|
0.3522 ng/mL
Standard Deviation 3.1629
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
5h
|
0.2631 ng/mL
Standard Deviation 3.2208
|
0.2344 ng/mL
Standard Deviation 2.7834
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
6h
|
0.3091 ng/mL
Standard Deviation 2.9830
|
0.2076 ng/mL
Standard Deviation 2.0474
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
8h
|
0.4032 ng/mL
Standard Deviation 3.1133
|
0.1863 ng/mL
Standard Deviation 3.4056
|
|
Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
10h
|
0.7918 ng/mL
Standard Deviation 3.4587
|
0.06873 ng/mL
Standard Deviation 3.0953
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: AUC(0-t) (Area Under Curve); area under the baseline-adjusted plasma concentration-time curve from time zero to the last sampling time point at which the concentration was at or above lower limit of quantification; t(last) is defined as the last value \>0 after baseline adjustment.
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=15 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
110.03 h*ng/mL
Standard Deviation 2.0
|
71.12 h*ng/mL
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: AUC(0-∞) (Area Under Curve); area under the baseline-adjusted plasma concentration-time data extrapolated to infinity
Outcome measures
| Measure |
Stratum: Face/Scalp
n=6 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=3 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
138.41 h*ng/mL
Standard Deviation 2.2
|
138.55 h*ng/mL
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: %AUC(t-∞) (Area Under Curve); proportion of extrapolated part
Outcome measures
| Measure |
Stratum: Face/Scalp
n=9 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=3 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
8.27 percentage of AUC (0-∞)
Standard Deviation 2.3
|
3.01 percentage of AUC (0-∞)
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: Cmax (Maximum Plasma Concentration); observed maximum baseline-adjusted plasma concentration
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=15 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
27.93 ng/mL
Standard Deviation 1.9
|
27.68 ng/mL
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: Tmax (time to reach Cmax)
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=15 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
3.0 h
Interval 1.55 to 3.5
|
3.42 h
Interval 0.47 to 6.0
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: λz (Elimination Rate Constant); λz denotes the terminal rate constant estimated by linear regression analysis from a range of concentrations in the terminal phase estimated for each treatment and subject by log-linear regression from the linear portion of the logarithmic transformed concentration-time plot. The algorithm will start with the last 3 points with quantifiable concentrations and increases the number of involved points by 1 until the time point after Cmax restricted on time points after removing of the BF-200 ALA gel (all PK samples after the gel is wiped off \[after 3h±10 min); λz was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing.
Outcome measures
| Measure |
Stratum: Face/Scalp
n=9 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=3 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
0.24 1/h
Standard Deviation 1.9
|
0.36 1/h
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: ALA Pharmacokinetic Set (PKS ALA): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: t1/2 (apparent terminal half-life); calculated by ln2/λz; t1/2 was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing.
Outcome measures
| Measure |
Stratum: Face/Scalp
n=9 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=3 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
|
2.86 h
Standard Deviation 1.9
|
1.93 h
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: AUC(0-t) (Area Under Curve); area under the baseline-adjusted plasma concentration-time curve from time zero to the last sampling time point at which the concentration was at or above lower limit of quantification; t(last) is defined as the last value \>0 after baseline adjustment.
Outcome measures
| Measure |
Stratum: Face/Scalp
n=13 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=9 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
0.88 h*ng/mL
Standard Deviation 4.6
|
0.68 h*ng/mL
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: AUC(0-∞) (Area Under Curve); area under the baseline-adjusted plasma concentration-time data extrapolated to infinity
Outcome measures
| Measure |
Stratum: Face/Scalp
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=1 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
—
|
0.77 h*ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: %AUC(t-∞) (Area Under Curve); proportion of extrapolated part
Outcome measures
| Measure |
Stratum: Face/Scalp
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=1 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
—
|
7.33 percentage of AUC (0-∞)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: Cmax (Maximum Plasma Concentration); observed maximum baseline-adjusted plasma concentration
Outcome measures
| Measure |
Stratum: Face/Scalp
n=13 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=9 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
0.48 ng/mL
Standard Deviation 2.2
|
0.34 ng/mL
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: Tmax (time to reach Cmax)
Outcome measures
| Measure |
Stratum: Face/Scalp
n=13 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=9 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
4.0 h
Interval 1.0 to 9.88
|
3.52 h
Interval 0.47 to 8.0
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: λz (Elimination Rate Constant); λz denotes the terminal rate constant estimated by linear regression analysis from a range of concentrations in the terminal phase estimated for each treatment and subject by log-linear regression from the linear portion of the logarithmic transformed concentration-time plot. The algorithm will start with the last 3 points with quantifiable concentrations and increases the number of involved points by 1 until the time point after Cmax restricted on time points after removing of the BF-200 ALA gel (all PK samples after the gel is wiped off \[after 3h±10 min); λz was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing.
Outcome measures
| Measure |
Stratum: Face/Scalp
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=1 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
—
|
0.35 1/h
Standard Deviation 0
|
SECONDARY outcome
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)Population: PpIX Pharmacokinetic Set (PKS PpIX): includes all subjects who had at least one evaluable pre-dose and post-dose pharmacokinetic sample (i.e., samples taken after the application of BF-200 ALA); a pre-dose/post-dose sample was regarded evaluable if the plasma concentration was at or above LLOQ.
Parameter: t1/2 (apparent terminal half-life); calculated by ln2/λz; t1/2 was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing.
Outcome measures
| Measure |
Stratum: Face/Scalp
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=1 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
|
—
|
1.95 h
Standard Deviation 0
|
SECONDARY outcome
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)Population: Safety analysis set (SAF): includes all subjects who underwent at least one of the following treatment procedures: preparation of the treatment field(s), application of BF-200 ALA, or illumination. If the conduct of any treatment procedures was not certain, the subject was to be included in the SAF.
Frequency of treatment-emergent adverse events (TEAEs),including serious adverse events (SAEs).
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site erythema
|
16 Participants
|
16 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site exfoliation
|
10 Participants
|
3 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site hyperaesthesia
|
2 Participants
|
2 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site induration
|
2 Participants
|
2 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site oedema
|
16 Participants
|
9 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site pain
|
16 Participants
|
16 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site paraesthesia
|
4 Participants
|
1 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site pruritus
|
4 Participants
|
6 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site scab
|
5 Participants
|
6 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site vesicles
|
1 Participants
|
2 Participants
|
|
Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Application site warmth
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)Population: Safety analysis set (SAF): includes all subjects who underwent at least one of the following treatment procedures: preparation of the treatment field(s), application of BF-200 ALA, or illumination. If the conduct of any treatment procedures was not certain, the subject was to be included in the SAF.
Assessment of pain at the application site using an 11-point Numeric Rating Scale (NRS-11) ranging from 0 (no pain) to 10 (worst imaginable pain)
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Assessment of Pain Intensity at the Application Site in Response to PDT With BF-200 ALA Under Maximal Use Conditions Using an 11-point Numeric Rating Scale (NRS-11), Where a Score of 0 Means "no Pain" and a Score of 10 Means "Worst Imaginable Pain".
|
8.1 score on a scale
Standard Deviation 2.0
|
6.0 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)Population: Safety analysis set (SAF): includes all subjects who underwent at least one of the following treatment procedures: preparation of the treatment field(s), application of BF-200 ALA, or illumination. If the conduct of any treatment procedures was not certain, the subject was to be included in the SAF.
Application site reactions: discomfort (burning, pain, itching, stinging, warmth, others)
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Burning
|
14 Participants
|
9 Participants
|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Itching
|
4 Participants
|
6 Participants
|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Other
|
8 Participants
|
1 Participants
|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Pain
|
15 Participants
|
7 Participants
|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Pain during PDT
|
16 Participants
|
16 Participants
|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Stinging
|
7 Participants
|
3 Participants
|
|
Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Warmth
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)Population: Safety analysis set (SAF): includes all subjects who underwent at least one of the following treatment procedures: preparation of the treatment field(s), application of BF-200 ALA, or illumination. If the conduct of any treatment procedures was not certain, the subject was to be included in the SAF.
Application site reactions: skin reactions (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flaking, scabbing/crusting, discharge/exudate, others); maximum severity of AE: mild, moderate, or severe
Outcome measures
| Measure |
Stratum: Face/Scalp
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 Participants
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Discharge/exudate
|
1 Participants
|
0 Participants
|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Oedema
|
16 Participants
|
9 Participants
|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Erythema
|
16 Participants
|
16 Participants
|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Induration
|
2 Participants
|
2 Participants
|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Other
|
12 Participants
|
4 Participants
|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Scabbing/crusting
|
5 Participants
|
6 Participants
|
|
Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
Scaling/flaking
|
2 Participants
|
3 Participants
|
Adverse Events
Stratum: Face/Scalp
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Stratum: Periphery
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stratum: Face/Scalp
n=16 participants at risk
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
Stratum: Periphery
n=16 participants at risk
• Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) • Each subject received three entire tubes of the IMP (2 g each, containing 156 mg ALA), resulting in a total dose of 468 mg ALA (free base) • The amount was sufficient to cover one treatment field (continuous field or discontinuous field with several patches), totaling approx. 60 cm² with BF-200 ALA gel at a thickness of approx. 1 mm • Treatment field(s) could be located on either the face/scalp or in the periphery (neck/trunk/extremities) excluding the genitalia (minimal distance of about 1 cm) • IMP dried for approx. 10 min • Subjects had to stay in a well-tempered environment during 3h incubation under light-blocking, occlusive dressing • Dressing was removed; remnant gel wiped off • Illumination with BF-RhodoLED® (10 min; 37 J/cm²) • In case of discontinuous treatment field(s), two BF-RhodoLED® lamps were used simultaneously • One single PDT was performed
|
|---|---|---|
|
General disorders
Application site erythema
|
100.0%
16/16 • Number of events 18 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
100.0%
16/16 • Number of events 19 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site exfoliation
|
62.5%
10/16 • Number of events 13 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
18.8%
3/16 • Number of events 4 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site hyperaesthesia
|
12.5%
2/16 • Number of events 3 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 2 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site induration
|
12.5%
2/16 • Number of events 3 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
12.5%
2/16 • Number of events 2 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site oedema
|
100.0%
16/16 • Number of events 18 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
56.2%
9/16 • Number of events 10 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site pain
|
100.0%
16/16 • Number of events 63 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
100.0%
16/16 • Number of events 44 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site paraesthesia
|
25.0%
4/16 • Number of events 5 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 2 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site pruritus
|
25.0%
4/16 • Number of events 4 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
37.5%
6/16 • Number of events 7 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site scab
|
31.2%
5/16 • Number of events 6 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
37.5%
6/16 • Number of events 6 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site vesicles
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
12.5%
2/16 • Number of events 4 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site warmth
|
25.0%
4/16 • Number of events 5 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site discharge
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site discolouration
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site erosion
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site fissure
|
6.2%
1/16 • Number of events 2 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 2 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
General disorders
Application site haemorrhage
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Immune system disorders
Seasonal allergy
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Infections and infestations
Application site pustules
|
6.2%
1/16 • Number of events 2 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Infections and infestations
Bacteriuria
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Infections and infestations
COVID-19
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Infections and infestations
Pyuria
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Nervous system disorders
Sinus headache
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
0.00%
0/16 • On treatment day until end of study approximately 4 weeks after treatment day (07 October 2020, study completion date).
TEAEs (treatment emergent adverse events) are defined as all AEs or SAEs that occurred after lesion preparation at Visit 2, which was at maximum one hour before IMP application (i.e. AE onset date/time ≥ date/time of IMP application (Visit 2) - 1 h).
|
Additional Information
Clinical Trial Department
Biofrontera Bioscience GmbH
Phone: +49 214 876 32
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee It is understood that no results or data shall be independently published by the Principal Investigator, the Institution, or its other Representatives prior to Sponsor's approval. The Principal Investigator may publish the results of his or her investigative findings under the Study to the extent they are included in the individual Study publication or as part of a comprehensive publication.
- Publication restrictions are in place
Restriction type: OTHER