Basal Cell Carcinoma (BCC)
Conditions
Keywords
Photodynamic Therapy, PDT, non-aggressive BCC
Brief summary
The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).
Detailed description
The treatment comprises of up to 2 PDT cycles, each with two PDT sessions one week apart. If 12 weeks after the the second PDT all lesions are completely cleared the patient will enter the follow-up phase. In case of remaining lesions the patient will receive a second PDT cycle starting on the same day.
Interventions
DRUGBF-200 ALA
Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
DRUGmethyl-aminolevulinate
Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
Sponsors
Accovion GmbH
Biofrontera Bioscience GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Willing and able to sign informed consent form; obtained in writing before starting any study procedures * Presence of 1-3 thin (≤2 mm thickness), clinically non-aggressive, primary BCC lesions (primary superficial, nodular, or mixed superficial/nodular) in the face/forehead, bald scalp, extremities and/or neck/trunk. Confirmation of non-aggressiveness and thickness of BCC through biopsies taken at screening for at least one lesion. Lesions non-eligible according to biopsy should timely be removed by surgery or cryotherapy * Diameters of lesions should range between ≥0.5cm and ≤2cm; total maximal treated area is 10cm² (including 0.5-1.0cm margin surrounding each lesion) * Target BCC lesions must be discrete and quantifiable and have to be located within 1-2 treatment areas * Free of significant physical abnormalities (eg tattoos, dermatoses) in potential treatment area that may cause difficulty with examination or final evaluation * Accept to abstain from extensive sunbathing and use of solarium during observer blind part. Patients with sunburn within treatment areas cannot be included until fully recovered * Healthy patients and patients with clinically stable medical conditions, including, but not limited to controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis, will be permitted to be included in study if their medication is not prohibited by protocol * Women of childbearing potential are permitted to participate in study only if they have a negative serum pregnancy test at screening and willingness to use a highly effective method of contraception during observer blind part Main
Exclusion criteria
* History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA, MAL or any ingredient of Metvix®, including arachis oil, or to peanut or soya * Hypersensitivity to porphyrins * Current treatment with immunosuppression therapy * Presence of porphyria * Presence of BCC lesions on embryonic fusion planes (H-zone) * Presence of more than 3 BCCs * Presence of malignant or benign tumors of the skin other than non-aggressive BCC within the treatment area (eg malignant melanoma, squamous cell carcinoma (SCC), aggressive BCC clinically diagnosed at screening) within the last 12 weeks * Gorlin Syndrome or Xeroderma pigmentosum * Presence of photodermatoses * Treatment of lesions (actinic keratosis (AK), BCC, SCC, Bowens disease, melanoma) ≤12 weeks prior to first PDT, except physical treatments (eg cryosurgery, excision surgery) that will not be allowed ≤6 weeks prior to first PDT (Visit 2). Lesion(s) that seemed eligible clinically which could not be confirmed by biopsy, and which are located ≥10cm to an eligible lesion should timely be removed physically only * Presence of inherited or acquired coagulation defect * Start of intake of medication with hypericin or systemically-acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening * Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic disease making implementation of protocol or interpretation of study results difficult * Evidence of clinically significant (CS), unstable medical conditions, eg: * Metastatic tumor or tumor with high probability of metastasis * Cardiovascular disease (New York Heart Association \[NYHA\] class III, IV) * Immunosuppressive condition * Hematologic, hepatic, renal, neurologic, or endocrine condition * Collagen-vascular condition * Gastrointestinal condition * Topical treatment with 5-ALA or MAL outside treatment area during the observer blind part * Any topical treatment including diclofenac and immunomodulatory agents (eg imiquimod, ingenol mebutate) 12 weeks prior to first PDT session and during observer blind part * Any physical treatment during the observer blind part within treated target areas with exception of lesion(s) determined non-eligible by biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Complete Response Assessed 12 Weeks After the Last PDT | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint. |
| Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint. Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris). |
| Patient Complete Response 12 Weeks After PDT-2 | 12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint. |
| Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline |
| Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Recurrence Rate (Overall, Cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT |
| Lesion Recurrence Rate (Cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)). |
Countries
Germany
Participant flow
Recruitment details
Trial was conducted in Germany and United Kingdom with a total of 24 sites who recruited patients. Enrollment of patients started (first patient enrolled) 28-Jan-2014.
Pre-assignment details
Of the 394 patients screened in this study, 281 patients were randomized (138 patients to BF-200 ALA and 143 patients to methyl-aminolevulinate) and treated. 113 patients were excluded before randomization due to screening failure (104 patients), patient's decision (7 patients), and lost to FU and other reason (each 1 patient).
Participants by arm
| Arm | Count |
|---|---|
| BF-200 ALA Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU. | 138 |
| Methyl-aminolevulinate Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU. | 143 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | no visits 7 & 8/no visits after visit 4 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | BF-200 ALA | Methyl-aminolevulinate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 86 Participants | 89 Participants | 175 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 54 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 142 Participants | 280 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 54 Participants | 68 Participants | 122 Participants |
| Sex: Female, Male Male | 84 Participants | 75 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 1 / 143 |
| other Total, other adverse events | 138 / 138 | 143 / 143 |
| serious Total, serious adverse events | 3 / 138 | 7 / 143 |
Outcome results
Primary
Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT
Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.
Time frame: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BF-200 ALA | Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT | 93.4 Percentage of Patients |
| Methyl-aminolevulinate | Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT | 91.8 Percentage of Patients |
p-value: <0.0001Farrington and Manning Test
Secondary
Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline
Time frame: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BF-200 ALA | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Good | 11.7 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Unsatisfactory | 14.2 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Satisfactory | 35.8 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Impaired | 15.0 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Very good | 23.3 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Impaired | 17.4 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Very good | 14.7 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Good | 18.3 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Satisfactory | 29.4 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Unsatisfactory | 20.2 Percentage of Patients |
Secondary
Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline
Time frame: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BF-200 ALA | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Good | 20.0 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Unsatisfactory | 11.4 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Satisfactory | 22.9 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Impaired | 5.7 Percentage of Patients |
| BF-200 ALA | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Very good | 40.0 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Impaired | 6.8 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Very good | 21.6 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Good | 27.0 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Satisfactory | 32.4 Percentage of Patients |
| Methyl-aminolevulinate | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | Unsatisfactory | 12.2 Percentage of Patients |
Secondary
Lesion Complete Response Assessed 12 Weeks After the Last PDT
Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint.
Time frame: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BF-200 ALA | Lesion Complete Response Assessed 12 Weeks After the Last PDT | 94.6 Percentage of Individual Lesions |
| Methyl-aminolevulinate | Lesion Complete Response Assessed 12 Weeks After the Last PDT | 92.9 Percentage of Individual Lesions |
Secondary
Patient Complete Response 12 Weeks After PDT-2
Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint.
Time frame: 12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BF-200 ALA | Patient Complete Response 12 Weeks After PDT-2 | 57.9 Percentage of Patients |
| Methyl-aminolevulinate | Patient Complete Response 12 Weeks After PDT-2 | 56.4 Percentage of Patients |
Secondary
Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline
Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint. Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris).
Time frame: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).
Population: Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BF-200 ALA | Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | -94.5 Percentage of Change | Standard Deviation 35.07 |
| Methyl-aminolevulinate | Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | -97.0 Percentage of Change | Standard Deviation 13.37 |
Other Pre-specified
Lesion Recurrence Rate (Cumulative)
Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)).
Time frame: 6, 12, 24, 36 and 60 months post-PDT
Population: Per protocol analysis in follow-up (PPS-FUP): All lesions in patients in the full analysis set in follow-up (FAS-FUP) without any major protocol deviations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BF-200 ALA | Lesion Recurrence Rate (Cumulative) | Overall | 13.5 percentage of lesions (cumulative) |
| BF-200 ALA | Lesion Recurrence Rate (Cumulative) | sBCC | 10.3 percentage of lesions (cumulative) |
| BF-200 ALA | Lesion Recurrence Rate (Cumulative) | nBCC | 25 percentage of lesions (cumulative) |
| Methyl-aminolevulinate | Lesion Recurrence Rate (Cumulative) | Overall | 13.4 percentage of lesions (cumulative) |
| Methyl-aminolevulinate | Lesion Recurrence Rate (Cumulative) | sBCC | 11.9 percentage of lesions (cumulative) |
| Methyl-aminolevulinate | Lesion Recurrence Rate (Cumulative) | nBCC | 21.4 percentage of lesions (cumulative) |
Other Pre-specified
Patient Recurrence Rate (Overall, Cumulative)
Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT
Time frame: 6, 12, 24, 36 and 60 months post-PDT
Population: Per protocol analysis set in the follow-up (PPS-FUP): all patients of the full analysis set in the follow-up (FAS-UP) without any major protocol deviations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BF-200 ALA | Patient Recurrence Rate (Overall, Cumulative) | 16.9 percentage of patients (cumulative) |
| Methyl-aminolevulinate | Patient Recurrence Rate (Overall, Cumulative) | 15.5 percentage of patients (cumulative) |