Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

NCT05740969 | Unknown Phase 2

• 1 other identifier: REG-163-2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Gene and protein expression profiles

  10 days of treatment

Secondary Outcomes (1)

• histopathological assessment of actinic keratoses

  10 days of treatment

Study Arms (4)

5-Fluorouracil

ACTIVE COMPARATOR

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

Imiquimod

ACTIVE COMPARATOR

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

Melatonin

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

5Fluorouracil DRUG

Cream

5-Fluorouracil

Imiquimod DRUG

Cream

Imiquimod

Melatonin DRUG

Cream

Melatonin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants should have a clinical diagnosis of actinic keratosis
• Participants should be 18 years old or above
• Participants must sign an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ismail Gögenur: lead

Study Sites (1)

Zealand University Hospital

Roskilde, Region Sjælland, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil; Imiquimod; Melatonin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ismail A. Gögenur, MD, DMSc

  Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jawad A Zahid, MD

CONTACT

+4551329815; jaza@regsj.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 23, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)