Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
NCT ID: NCT05740969
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2023-02-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5-Fluorouracil
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.
5Fluorouracil
Cream
Imiquimod
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.
Imiquimod
Cream
Melatonin
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.
Melatonin
Cream
Control
A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary.
No interventions assigned to this group
Interventions
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5Fluorouracil
Cream
Imiquimod
Cream
Melatonin
Cream
Eligibility Criteria
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Inclusion Criteria
* Participants should be 18 years old or above
* Participants must sign an informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ismail Gögenur
OTHER
Responsible Party
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Ismail Gögenur
Professor
Principal Investigators
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Ismail A. Gögenur, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial
Locations
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Zealand University Hospital
Roskilde, Region Sjælland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Jawad A Zahid, MD
Role: primary
Other Identifiers
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REG-163-2021
Identifier Type: -
Identifier Source: org_study_id
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