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The primary aim of this study is to investigate the effect of 5-fluorouracil, imiquimod, and melatonin for actinic keratosis on immunological gene, and protein expressions profiles. Secondarily, the aim is to assess the effect of the treatment on the histopathology of actinic keratoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-Fluorouracil | Active Comparator | Patients will be asked apply a 40 mg/g creme containing 5-Fluorouracil once a day on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary. |
|
| Imiquimod | Active Comparator | Patients will be asked apply a 50 mg/g creme containing imiquimod thrice a week on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary. |
|
| Melatonin | Experimental | Patients will be asked apply a 25 mg/g creme containing melatonin once a day on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary. |
|
| Control | No Intervention | A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5Fluorouracil | Drug | Cream |
| |
| Imiquimod |
| Measure | Description | Time Frame |
|---|---|---|
| Gene and protein expression profiles | 10 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| histopathological assessment of actinic keratoses | 10 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jawad A Zahid, MD | Contact | +4551329815 | jaza@regsj.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ismail A. Gögenur, MD, DMSc | Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Recruiting | Roskilde | Region Sjælland | 4600 | Denmark |
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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 |
|---|---|
| D005472 | Fluorouracil |
| D000077271 | Imiquimod |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
Cream |
|
| Melatonin | Drug | Cream |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |