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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003241-42 | EudraCT Number |
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| Name | Class |
|---|---|
| Accovion GmbH | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF-200 ALA | Active Comparator | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin. |
|
| methyl-aminolevulinate | Active Comparator | Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF-200 ALA | Drug | Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6, 12, 24, 36 and 60 months post-PDT |
| Lesion Recurrence Rate (Cumulative) |
Main Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Rolf M. Szeimies, Prof. Dr. | Klinik fuer Dermatologie und Allergologie (Klinikum Vest - Knappschaftskrankenhaus), Recklinghausen, Germany | Principal Investigator |
| Colin Morton, Dr. | Dermatology Department, Stirling Community Hospital, NHS Forth Valley, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Vest GmbH | Recklinghausen | Westfalen-Lippe | 45657 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29432644 | Result | Morton CA, Dominicus R, Radny P, Dirschka T, Hauschild A, Reinhold U, Aschoff R, Ulrich M, Keohane S, Ekanayake-Bohlig S, Ibbotson S, Ostendorf R, Berking C, Grone D, Schulze HJ, Ockenfels HM, Jasnoch V, Kurzen H, Sebastian M, Stege H, Staubach P, Gupta G, Hubinger F, Ziabreva I, Schmitz B, Gertzmann A, Lubbert H, Szeimies RM. A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF-200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive basal cell carcinoma with photodynamic therapy. Br J Dermatol. 2018 Aug;179(2):309-319. doi: 10.1111/bjd.16441. Epub 2018 May 16. |
| Label | URL |
|---|---|
| US National Library of Medicine National Institutes of Health | View source |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | BF-200 ALA | Topical application of BF-200 ALA gel (78 mg/g 5-aminolevulinic acid). The dose of BF-200 ALA was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated with by applying 2 additional PDTs in a second PDT cycle and then entered FU. |
| FG001 | Methyl-aminolevulinate | Topical application of methyl-aminolevulinate (MAL;160 mg/g). The dose of MAL was up to 1 g per PDT session (depending on size and number of target lesions located on neck, trunk, extremities, face or scalp, no more than 2 illumination areas with a maximum area incl. margin of 10cm², and a film thickness of about 1mm). Up to 4 administrations of study treatment (i.e. PDT sessions: drug application and subsequent illumination with BF-RhodoLED after 3h of drug incubation) were applied. For all patients, PDT-1 was to be administered directly after randomization and PDT-2 was to be administered approximately 1 week later. The total number of PDT sessions per patient depended on response as follows: Complete responders (all lesions totally cleared clinically) 12 weeks after PDT-2: entered the FU part with no further treatment. Partial or non-responders 12 weeks after PDT-2 were retreated by applying 2 additional PDTs in a second PDT cycle and then entered FU. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of Patients | 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). |
|
Each subject was assessed for a maximum of approximately 6 months after randomization depending on whether they received a second PDT cycle or not. Complete responders after the first PDT cycle were assessed for approximately 3 months after randomization. Additionally, there was a pre-randomization period of max. 2 weeks per patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular trachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Department | Biofrontera Bioscience GmbH | +49 214 876 32 66 | ameluz@biofrontera.com |
Not provided
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C570703 | BF-200 ALA |
| D000622 | Aminolevulinic Acid |
| C475457 | methyl 5-aminolevulinate |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| methyl-aminolevulinate | Drug | Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation) |
|
|
| 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). | 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). |
| 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. | 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). |
| 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:
Cosmetic outcome categories are:
| 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). |
| 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:
Cosmetic outcome categories are:
| 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 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)). |
| 6, 12, 24, 36 and 60 months post-PDT |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Death |
|
| no visits 7 & 8/no visits after visit 4 |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of Individual Lesions | 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). | individual lesions | individual lesions |
|
|
|
| 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). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Posted | Mean | Standard Deviation | Percentage of Change | 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). |
|
|
|
| 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. | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of Patients | 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). |
|
|
|
| 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:
Cosmetic outcome categories are:
| Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of Patients | 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). |
|
|
|
| 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:
Cosmetic outcome categories are:
| Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of Patients | 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). |
|
|
|
| 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 | 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 | Posted | Number | percentage of patients (cumulative) | 6, 12, 24, 36 and 60 months post-PDT |
|
|
|
| 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)). | 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 | Posted | Number | percentage of lesions (cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Lesions | Lesions |
|
|
|
| 0 |
| 138 |
| 3 |
| 138 |
| 138 |
| 138 |
| EG001 | 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. | 1 | 143 | 7 | 143 | 143 | 143 |
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site scab | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site induration | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site discharge | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site exfoliation | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site erosion | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site vesicles | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Application site discolouration | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor will review results communications prior to public release and has to approve in order to ensure the adequate reporting of study results. The sponsor can't refuse publication for unfair reasons.
| D018295 |
| Neoplasms, Basal Cell |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Satisfactory |
|
| Unsatisfactory |
|
| Impaired |
|
| Satisfactory |
|
| Unsatisfactory |
|
| Impaired |
|
|
| sBCC |
|
|
| nBCC |
|
|