Gene and Protein Expression Profiles After Treatment of Actinic Keratoses (PACKS)

Ismail Gögenur

Status and phase: Enrolling; Phase 2

Conditions: Actinic Keratoses

Treatments: Drug: Imiquimod; Drug: Melatonin; Drug: 5Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT05740969

REG-163-2021

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

5-Fluorouracil

Active Comparator group

Description:

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.

Treatment:

Drug: 5Fluorouracil

Imiquimod

Active Comparator group

Description:

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.

Treatment:

Drug: Imiquimod

Melatonin

Experimental group

Description:

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.

Treatment:

Drug: Melatonin

Control

No Intervention group

Description:

A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary.