Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Study Overview
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Brief Summary
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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.

Official Title
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Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: 5Fluorouracil
* Drug: Imiquimod
* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants should have a clinical diagnosis of actinic keratosis Participants should be 18 years old or above Participants must sign an informed consent Exclusion Criteria: Known allergic reaction to either 5-fluorouracil , imiquimod, or melatonin Immunomodulating treatment Predictable poor compliance (due to i.e. dementia, substance abuse, psychiatric disease, life-threatening disease or language barriers) Pregnant or breastfeeding Females not in menopause (defined as no menstruation during the last 12 months) should use a secure birth control (intrauterine devices, hormonal contraceptives including - oral pills, patches, vaginal rings and injections) during the entire period of the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5-Fluorouracil<br>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. | Drug: 5Fluorouracil<br>* Cream<br>|
| Active Comparator: Imiquimod<br>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. | Drug: Imiquimod<br>* Cream<br>|
| Experimental: Melatonin<br>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. | Drug: Melatonin<br>* Cream<br>|
| No Intervention: Control<br>A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene and protein expression profiles |  | 10 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histopathological assessment of actinic keratoses |  | 10 days of treatment |