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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002746-50 | EudraCT Number |
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| Name | Class |
|---|---|
| Tampere University | OTHER |
| University of Jyvaskyla | OTHER |
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This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hexylaminolevulinate cream | Experimental | 2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream |
|
| Aminolevulinic Acid Nano Emulsion | Experimental | 78 mg/g Aminolevulinic Acid Nano Emulsion |
|
| Methylaminolevulinate cream | Active Comparator | 160 mg/g Methylaminolevulinate cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexylaminolevulinate cream | Drug | The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological lesion clearance | 3 months | |
| Histological lesion clearance | 12 months | |
| Histological lesion clearance | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of subclinical lesion with hyperspectral imaging system | 3 months | |
| Detection of subclinical lesion with hyperspectral imaging system | 12 months | |
| Detection of subclinical lesion with hyperspectral imaging system |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescence measured in A.U. (Arbitrary Units) with standardised set-up, with Wood's light, digital camera and a yellow lens | before (point 0 min) and after (point 8 min) the exposure | |
| Pain in VAS-scale | in the beginning (point 0 min), middle (point 4 min) and end (point 8 min) of the exposure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mari Grönroos, MD, PhD | Päijänne Tavastia Central Hospital | Study Director |
| Mari K Salmivuori, MD | Päijänne Tavastia Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Authority for Päijät-Häme Social and Health Care | Lahti | 15850 | Finland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 31, 2021 | |
| Reset | Dec 21, 2021 | |
| Release | Mar 14, 2025 |
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|
| Aminolevulinic Acid Nano Emulsion | Drug | In the study we use Ameluz. |
|
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| Methylaminolevulinate cream | Drug | In the study we use Metvix. |
|
|
| 5 years |
| Reset | Apr 3, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 31, 2021 | Dec 21, 2021 | |||
| Mar 14, 2025 | Apr 3, 2025 |
| ID | Term |
|---|---|
| D018295 | Neoplasms, Basal Cell |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
| D000622 | Aminolevulinic Acid |
| C570703 | BF-200 ALA |
| C475457 | methyl 5-aminolevulinate |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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