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

February 13, 2023 updated by: Ismail Gögenur
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jawad A Zahid, MD
  • Phone Number: +4551329815
  • Email: jaza@regsj.dk

Study Locations

  • Denmark
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, 4600
        • Recruiting
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 5Fluorouracil
Cream
Active Comparator: 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.
Drug: Imiquimod
Cream
Experimental: 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.
Drug: Melatonin
Cream
No Intervention: Control
A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gene and protein expression profiles
Time Frame: 10 days of treatment
10 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
histopathological assessment of actinic keratoses
Time Frame: 10 days of treatment
10 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ismail Gögenur

Investigators

  • Principal Investigator: Ismail A. Gögenur, MD, DMSc, Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-163-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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