To hear about similar clinical trials, please enter your email below
Trial Title:
Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
NCT ID:
NCT05740969
Condition:
Actinic Keratoses
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Fluorouracil
Imiquimod
Melatonin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
5Fluorouracil
Description:
Cream
Arm group label:
5-Fluorouracil
Intervention type:
Drug
Intervention name:
Imiquimod
Description:
Cream
Arm group label:
Imiquimod
Intervention type:
Drug
Intervention name:
Melatonin
Description:
Cream
Arm group label:
Melatonin
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zealand University Hospital
Address:
City:
Roskilde
Zip:
4600
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Jawad A Zahid, MD
Start date:
February 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Ismail Gögenur
Agency class:
Other
Source:
Zealand University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740969
