Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

NCT ID: NCT05740969

Last Updated: 2023-02-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

5Fluorouracil

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Imiquimod

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Cream

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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5Fluorouracil

Cream

Intervention Type DRUG

Imiquimod

Cream

Intervention Type DRUG

Melatonin

Cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ismail Gögenur

OTHER

Sponsor Role lead

Responsible Party

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Ismail Gögenur

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jawad A Zahid, MD

Role: CONTACT

+4551329815

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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