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| Name | Class |
|---|---|
| Accovion GmbH | INDUSTRY |
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The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.
This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-[5-amino-4-oxopentanoate]) and placebo, for the treatment of AK with PDT.
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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 (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. |
|
| MAL Cream | Active Comparator | Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. |
|
| Vehicle | Placebo Comparator | Topical application of matched Placebo to BF-200 ALA gel (without containing active ingredient) ). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF-200 ALA | Drug | topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (~630 nm). An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT. | 3-4 weeks after the first PDT |
| Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT) |
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Main Inclusion Criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Dirschka, Prof. Dr. | Akademische Lehrpraxis der Universität Witten-Herdecke Heinz-Fangman-Straße 57 42287 Wuppertal | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21910711 | Background | Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Helwig C, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo. Br J Dermatol. 2012 Jan;166(1):137-46. doi: 10.1111/j.1365-2133.2011.10613.x. Epub 2011 Dec 21. | |
| 23252768 |
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616 patients with actinic keratosis (AK) were planned to be randomized in a 3:3:1 ratio allowing for 20% of non-evaluable patients excluded from the per-protocol set. Due to the low drop out rates, recruiting was stopped after 600 patients were screened. Of those, 571 patients were randomized and 29 patients were screening failures.
Multinational / 26 centers sites: Germany (23), Austria (2) and Switzerland (1); 08 Apr 2008: First subject signed informed consent; 21 Aug 2009: Last subject completed clinical part of study
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| FG001 | BF-200 ALA | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| FG002 | MAL Cream | Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intended-to-treat (ITT)
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| 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 | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) | Intent-to-treat (ITT) | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
|
Until 12 weeks after the last treatment
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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 | Vehicle | Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site irritation | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beate Schmitz | Biofrontera Bioscience GmbH | +49 214 876 32 | 41 | b.schmitz@biofrontera.com |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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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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|
| MAL Cream | Drug | topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
|
|
| Vehicle | Drug | topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
|
|
A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT. |
| 12 weeks after the first PDT |
| Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
| Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. | 12 weeks after the second PDT, 24 weeks after first treatment |
| Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT) | A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT). | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment |
| Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT. | 3-4 weeks after the first PDT |
| Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT. | 12 weeks after the first PDT |
| Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT. A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT. | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
| Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT. A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT. | 12 weeks after the second PDT, 24 weeks after first treatment |
| Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT. The outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT). | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment |
| Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT. The outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) . | 12 weeks after the last PDT, up to 24 weeks after first treatment |
| Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT) | Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT) | 3-4 weeks after the first PDT |
| Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT) | Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT). | 12 weeks after the first PDT |
| Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT) | Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT. | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
| Complete Lesion Response Rate 12 Weeks After Second PDT | Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT. | 12 weeks after the second PDT, 24 weeks after first treatment |
| Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT) | Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT). | 3-4 weeks after the last PDT, up to 16 weeks after first treatment |
| Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT) | Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT). | 12 weeks after the last PDT, up to 24 weeks after first treatment |
| Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT. Lesions were illuminated during photodynamic therapy with narrow spectrum devices only (~630 nm). | up to 12 weeks after the last PDT, up to 24 weeks after first treatment |
| Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT) | Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT. | 3-4 weeks after the first PDT |
| Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT. | 12 weeks after the first PDT |
| Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT. | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
| Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT. | 12 weeks after the second PDT, 24 after first treatment |
| Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT). | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment |
| Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT). | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
| Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline | The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline. | 12 weeks after the last PDT, up to 24 weeks after first treatment |
| Local Skin Reactions During First Photodynamic Therapy (PDT-1) | Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1) | during PDT treatment [3 h - 4 h ] |
| Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects | Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data). | during PDT treatment [3 h - 4 h ] |
| Local Discomfort During First Photodynamic Therapy (PDT-1) | Local discomfort reported by the patients during Illumination of first PDT (PDT1) | during PDT treatment [3 h - 4 h ] |
| Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects | Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data) | during PDT treatment [3 h - 4 h ] |
| Local Discomfort - Pain During First Photodynamic Therapy (PDT-1) | Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT. | during PDT treatment [3 h - 4 h ] |
| Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects | Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. Only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data) | during PDT treatment [3 h - 4 h ] |
| Adverse Reactions | Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of >=5%. TEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy. The safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment. | up to 12 weeks after the last PDT, up to 24 weeks after first treatment |
| Background |
| Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Hahn S, Pabst G, Voss D, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group; AK-CT003 Study Group. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013 Apr;168(4):825-36. doi: 10.1111/bjd.12158. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG001 | BF-200 ALA | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| BG002 | MAL Cream | Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of individual lesions | Number | individual lesions |
|
| OG001 | BF-200 ALA | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
| OG002 | MAL Cream | Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. |
|
|
|
| Primary | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) | per protocol set (PP) | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
|
|
|
|
| Primary | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (~630 nm). An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
|
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|
|
| Secondary | Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 3-4 weeks after the first PDT |
|
|
|
| Secondary | Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the first PDT |
|
|
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| Secondary | Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
|
|
|
| Secondary | Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT) | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the second PDT, 24 weeks after first treatment |
|
|
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| Secondary | Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT) | A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT). | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment |
|
|
|
| Secondary | Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 3-4 weeks after the first PDT |
|
|
|
| Secondary | Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the first PDT |
|
|
|
| Secondary | Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT. A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
|
|
|
| Secondary | Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT. A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the second PDT, 24 weeks after first treatment |
|
|
|
| Secondary | Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT. The outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT). | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment |
|
|
|
| Secondary | Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT) | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT. The outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) . | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the last PDT, up to 24 weeks after first treatment |
|
|
|
| Secondary | Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT) | Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT) | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | 3-4 weeks after the first PDT | number of individual lesions | number of individual lesions |
|
|
|
| Secondary | Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT) | Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT). | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | 12 weeks after the first PDT | number of individual lesions | number of individual lesions |
|
|
|
| Secondary | Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT) | Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | 3-4 weeks after the second PDT, 15-16 weeks after first treatment | number of individiual lesions | number of individiual lesions |
|
|
|
| Secondary | Complete Lesion Response Rate 12 Weeks After Second PDT | Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT. | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | 12 weeks after the second PDT, 24 weeks after first treatment | number of individual lesions | number of individual lesions |
|
|
|
| Secondary | Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT) | Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT). | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | 3-4 weeks after the last PDT, up to 16 weeks after first treatment | number of individual lesions | number of individual lesions |
|
|
|
| Secondary | Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT) | Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT). | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | 12 weeks after the last PDT, up to 24 weeks after first treatment | num,ber of individual lesions | num,ber of individual lesions |
|
|
|
| Secondary | Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT. Lesions were illuminated during photodynamic therapy with narrow spectrum devices only (~630 nm). | ITT | Posted | Number | 95% Confidence Interval | percentage of lesions | up to 12 weeks after the last PDT, up to 24 weeks after first treatment | lesions treated with narrow spectrum | lesions treated with narrow spectrum |
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|
| Secondary | Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT) | Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT. | ITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 3-4 weeks after the first PDT |
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|
|
| Secondary | Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT. | ITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 12 weeks after the first PDT |
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|
|
| Secondary | Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT. | ITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 3-4 weeks after the second PDT, 15-16 weeks after first treatment |
|
|
|
| Secondary | Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT. | ITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 12 weeks after the second PDT, 24 after first treatment |
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|
| Secondary | Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT). | ITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment |
|
|
|
| Secondary | Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT) | the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT). | ITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 12 weeks after the last PDT, up to 24 weeks after the first treatment |
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|
| Secondary | Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline | The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline. | ITT | Posted | Number | 95% Confidence Interval | percentage of patients | 12 weeks after the last PDT, up to 24 weeks after first treatment |
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| Secondary | Local Skin Reactions During First Photodynamic Therapy (PDT-1) | Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1) | Safety Population | Posted | Number | percentage of patients | during PDT treatment [3 h - 4 h ] |
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| Secondary | Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects | Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data). | Safety Population - retreated subjects only | Posted | Number | percentage of patients | during PDT treatment [3 h - 4 h ] |
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| Secondary | Local Discomfort During First Photodynamic Therapy (PDT-1) | Local discomfort reported by the patients during Illumination of first PDT (PDT1) | Safety Population | Posted | Number | percentage of patients | during PDT treatment [3 h - 4 h ] |
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|
|
| Secondary | Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects | Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data) | Safety Population - retreated subjects only | Posted | Number | percentage of patients | during PDT treatment [3 h - 4 h ] |
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|
|
| Secondary | Local Discomfort - Pain During First Photodynamic Therapy (PDT-1) | Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT. | Safety Population | Posted | Mean | Standard Deviation | units on a scale | during PDT treatment [3 h - 4 h ] |
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| Secondary | Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects | Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. Only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data) | Safety Population | Posted | Mean | Standard Deviation | units on a scale | during PDT treatment [3 h - 4 h ] |
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| Secondary | Adverse Reactions | Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of >=5%. TEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy. The safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment. | safety population | Posted | Count of Participants | Participants | up to 12 weeks after the last PDT, up to 24 weeks after first treatment |
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|
|
| 3 |
| 76 |
| 55 |
| 76 |
| EG001 | BF-200 ALA | Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. | 11 | 248 | 239 | 248 |
| EG002 | MAL Cream | Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. | 10 | 246 | 241 | 246 |
| Arrhythmia | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Non-Hodgkin's lymphoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Arterial stenosis limb | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site edema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site exfoliation | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site scab | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site induration | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site vesicles | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
The publication of study results requires Biofrontera's acceptance. Investigators can claim an authorship if they have completely treated and documented at least 35 patients. Planned publications and presentations of investigations which are within the scope of the clinical study should be previously presented to Biofrontera for a statement.
| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Chi-squared | 0.0000 | Difference to BF-200 ALA | 59.4 | 2-Sided | 95 | 48.4 | 70.4 | Superiority or Other |
| Difference to BF-200 ALA |
| 17.3 |
| 1-Sided |
| 97.5 |
| 6.6 |
| Superiority or Other |
|
| good |
|
| Satisfactory |
|
| Unsatisfactory |
|
| Impaired |
|
| Title | Measurements |
|---|---|
|
| Induration |
|
| Vesicles |
|
| Erosion |
|
| Ulceration |
|
| Scaling/Flaking |
|
| Scabbing/Crusting |
|
| Weeping/Exudate |
|
| Title | Measurements |
|---|---|
|
| Induration |
|
| Vesicles |
|
| Erosion |
|
| Ulceration |
|
| Scaling/Flaking |
|
| Scabbing/Crusting |
|
| Weeping/Exudate |
|
|
|
|
| Application site pain |
|
| Application site edema |
|
| Application site pruritus |
|
| Application site exfoliation |
|
| Application site scab |
|
| Application site induration |
|
| Application site vesicles |
|
| Application site paraesthesia |
|
| Skin exfoliation |
|