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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020179-22 | EudraCT Number |
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Nodular Basal Cell Carcinomas:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.
Actinic keratosis:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK split-face treatment | Active Comparator | Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT. |
|
| Fractional laser assisted PDT for BCC | Active Comparator | Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT. |
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| Konventional PDT for BCC | Active Comparator | Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional photodynamic therapy | Drug | Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | Clinical evaluation by a blinded physician. | 3 months |
| Reoccurrence | Clinical evaluation by a blinded physician | 12 months |
| Treatment response | Blinded histological examination from patients with basal cell carcinomas | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Patient score (VAS 0-10) | during laser and PDT |
| Adverse effects | scaring, hyper- and hypopigmentation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete Hædersdal, PhD,DrMedSci | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Bispebjerg Hospital | Copenhagen | DK-2400 | Denmark |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| Fractional CO2 laser assisted PDT | Drug | Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT |
|
| Fluorescence | Methyl-amonolevulinate uptake | 3 hours |
| Cosmetic result | 4-point scale | 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018295 | Neoplasms, Basal Cell |