| Primary | Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | TEAEs are defined as all AEs with onset or worsening after treatment with IMP up to Visit 5 (Final Visit). TEAEs are considered being related to IMP or medical device, if causal relationship between IMP or medical device and the TEAE is at least possible or relationship assessment is missing. If an AE occurs in different treatment areas (face, scalp, face and scalp), it is reported separately for each treatment area. Thus, some AEs are counted more than once. | | Posted | | Number | | Number of events | | Through study completion, on average 6 weeks | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
| | | Title | Denominators | Categories |
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| Any AEs | | | | Any AEs : mild | | | | Any AEs : moderate | | |
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| Primary | Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe). | The duration of TEAEs related to IMP and/or medical device which occurred in at least two subjects and with complete start and stop dates was analyzed. In addition, the proportion of the duration by severity was analyzed. Duration of severity per subject and preferred term is calculated in days counting all days and all episodes of one severity category together. Calculation is done referring to all subjects with occurrence of respective preferred term. If a severity category of a preferred term does not occur in a subject, the duration of this category is set to 0. If an AE occurs in different treatment areas, it is reported separately for each treatment area (face, scalp, face and scalp). Thus, some AEs are counted more than once for the analysis. | | Posted | | Mean | Standard Deviation | days | | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field | Assessed were newly occuring lesions of actinic keratosis (AK), non-melanoma skin cancer (NMSC) such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) or Bowens disease, and melanoma inside the treatment field. Cumulative number of lesions is reported. | | Posted | | Number | | Number of lesions | | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm | Assessed were newly occuring lesions of actinic keratosis (AK), non-melanoma skin cancer (NMSC) such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) or Bowens disease, and melanoma inside the treatment field. Cumulative number of lesions is reported. | | Posted | | Number | | Number of lesions | | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Application Site Skin Reactions During and Post PDT, Assessed by the Investigator | Application site skin reaction categories: discharge, erosion, erythema, exfoliation, fissure, induration, oedema, scabbing, skin flaking, ulceration, vesicles, other; severity of AE: mild, moderate or severe | | Posted | | Number | | percentage of partcipants | | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Application Site Discomfort During and Post PDT, Reported by the Subjects | Application site discomfort categories: burning, hyperaesthesia, pain, paraesthesia, pruritus, stinging, warmth, other; severity of AE: mild, moderate or severe | | Posted | | Number | | percentage of participants | | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Application Site Pain During Illumination | Assessed by the subjects using an 11-point numeric rating scale (NRS), where a score of 0 means "no pain" and a score of 10 means "worst imaginable pain". | For this study, concomitant medication as pain-relieving measure prior to illumination, concomitant medications given as pain-relieving measures during illumination and physical pain-relieving measures (i.e. interruption of the illumination and/or cooling with an air stream and/or nebulized water) were allowed. Subjects might have received a combination of medications (prior and/or during) and/or measures. | Posted | | Mean | Standard Deviation | score on a scale | | At treatment day (day 1, Visit 2) after end of illumination | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Changes in Blood Pressure (Systolic and Diastolic) | Change from baseline is presented. The first measurement at Visit 2 (arrival at site) was considered as baseline value for all following measurements. Blood pressure was measured in mmHg. At Visit 2, photodynamic therapy was performed. | One subject had elevated systolic and diastolic blood pressure at Visit 1 which was considered clinically significant and thus documented as relevant medical history. At Visit 2, blood pressure data was missing for one subject for the timepoint 'within 10 min prior to illumination', and for two subjects for the timepoint '60 min after illumination'. One subject missed Visit 3 and thus had no vital sign measurements at Visit 3. | Posted | | Mean | Standard Deviation | mmHg | | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Changes in Pulse Rate | Change from baseline is presented. The first measurement at Visit 2 (arrival at the site) was considered as baseline value for all following measurements. Pulse rate was measures in beats/min. At Visit 2, photodynamic therapy was performed. | At Visit 2, pulse rate data was missing for one subject for the timepoint 'within 10 min prior to illumination', and for two subjects for the timepoint '60 min after illumination'. One subject missed Visit 3 and thus had no vital sign measurements at Visit 3. | Posted | | Mean | Standard Deviation | beats per min | | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Changes in Body Temperature | Change from baseline is presented. The first measurement at Visit 2 (arrival at site) was considered as baseline value for all following measurements. Body temperature was measured in °F and was converted to °C in the electronic Case Report Form. At Visit 2, photodynamic therapy was performed. | At Visit 2, body temperature data was missing for one subject for the timepoint 'within 10 min prior to illumination', and for three subjects for the timepoint '60 min after illumination'. One subject missed Visit 3 and thus had no vital sign measurement at Visit 3. For one other subject, no temperature data was available at Visit 3. | Posted | | Mean | Standard Deviation | °C | | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Investigation of Clinical Chemistry Parameters | Findings which differ from reference range and are considered to be clinically significant are to be reported. Clinical chemistry parameters include glucose, creatinine, total bilirubin, aspartate aminotransferase (AST), alanineaminotransferase (ALT), lactate dehydrogenase (LDH), alkalinephosphatase (AP),gamma glutamyl transferase (GGT), potassium, sodium, calcium, total protein, albumin. | Visit 1: For one subject, clinical chemistry but no hematology parameters were analyzed, as the sample arrived at the analyzing laboratory too late. However, no clinical chemistry measurements were documented for this subject. One other subject had no blood sample collected at Visit 1. Visit 5: One subject had no hematology and clinical chemistry assessment at Visit 5, as the blood sample was inadvertently not collected. | Posted | | Number | | participants with findings considered CS | | At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Investigation of Hematology Parameters | Findings which differ from reference range and are considered to be clinically significant are to be reported. Hematology parameters include hemoglobin, hematocrit, red blood cell count, leukocyte count (white blood cells(WBC)) with differential count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count. | Visit 1: For one subject, clinical chemistry but no hematology parameters were analyzed, as the sample arrived at the analyzing laboratory too late. However, no clinical chemistry measurements were documented for this subject. One other subject had no blood sample collected at Visit 1. Visit 5: One subject had no hematology and clinical chemistry assessment at Visit 5, as the blood sample was inadvertently not collected. | Posted | | Number | | participants with findings considered CS | | At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Investigation of Urinalysis Parameters | Findings which differ from reference range and are considered to be clinically significant (CS) are to be reported | Reasons for missing urinalysis data for 3 subjects at Visit 5 were "study coordinator error" (n=2) and "urinalysis inadvertently not collected" (n=1). | Posted | | Number | | participants with findings considered CS | | At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Physical Examination of Head, Neck, Skin, Lymph Nodes, Thorax Including Heart and Lungs, Abdomen, and Musculoskeletal, Peripheral Vascular and Nervous System Status | Abnormal findings, considered to be clinically significant (CS), are to be reported | At Visit 1, one participant had findings considered clinically significant. Of this 1 participant, these findings concerned the nervous system. | Posted | | Number | | participants with findings considered CS | | At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Memory Tests | Including picture- and question-based memory tasks; abnormal findings that are considered clinically significant will be documented | Four subjects had missing data at Visit 1. | Posted | | Count of Participants | | Participants | | At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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| Primary | Neurological Investigations | Including investigation of pupils (equality), coordination (finger-nose test), gait (balance), and sensitivity (cheeks, arms, legs); abnormal findings that are considered clinically significant (CS) will be documented | One subject had no sensitivity assessment at Visit 1, and one other subject had no sensitivity assessment at Visit 2 after end of illumination. | Posted | | Number | | participants with findings considered CS | | At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1) | | | | ID | Title | Description |
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| OG000 | Total (BF-200 ALA) | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). BF-200 ALA and red light LED lamp: Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²) on the face and/or scalp, followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. |
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