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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004512-22 | EudraCT Number |
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The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone | Active Comparator | kortikosteroid |
|
| 5-fluorouracil | Active Comparator | antimitotic drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-fluorouracil | Drug | antimitotic drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms (pain, itching) of keloids and appearance of keloid | Change from baseline symptoms of scars baseline at one year with POSAS score | baseline and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration change of hemoglobin and melanin | Camera analysis with spectrocutometry | 0 week, 3 week, 6 week, 12 week, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory cells and their different populations, blood vessel density, fibroplast proliferation (KI67) and estrogenreseptor | immonuhistochemical analysis with punch biopsy | 0 week, 3 week, 6 week, 12 week, 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere university hospital | Tampere | 33521 | Finland |
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| Triamcinolone | Drug |
|
|
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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