Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Phase 2

Recruiting

• Conditions: Actinic Keratoses
• Interventions: Drug: Melatonin; Drug: Imiquimod; Drug: 5Fluorouracil

• Registration Number: NCT05740969
• Lead Sponsor: Ismail Gögenur

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23
• Primary Completion: 2024-02-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	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.
Imiquimod	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.
5-Fluorouracil	5Fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
Gene and protein expression profiles	10 days of treatment

Secondary Outcome Measures

Name	Time	Method
histopathological assessment of actinic keratoses	10 days of treatment

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Region Sjælland, Denmark