Actinic Keratoses
Conditions
Brief summary
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.
Interventions
DRUG5Fluorouracil
Cream
DRUGImiquimod
Cream
DRUGMelatonin
Cream
Sponsors
Ismail Gögenur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gene and protein expression profiles | 10 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| histopathological assessment of actinic keratoses | 10 days of treatment |
Countries
Denmark
Contacts
Primary ContactJawad A Zahid, MD
Outcome results
None listed