PACKS: Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Sponsor

Ismail Gögenur (Other)

Overall Status

Recruiting

CT.gov ID

NCT05740969

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Drug: 5Fluorouracil Drug: Imiquimod Drug: Melatonin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Gene and protein expression profiles [10 days of treatment]

Secondary Outcome Measures

histopathological assessment of actinic keratoses [10 days of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zealand University Hospital	Roskilde	Region Sjælland	Denmark	4600

Sponsors and Collaborators

Ismail Gögenur

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ismail Gögenur, Professor, Zealand University Hospital

ClinicalTrials.gov Identifier:

NCT05740969

Other Study ID Numbers:

REG-163-2021

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023