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

Primary Purpose

Actinic Keratoses

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
5Fluorouracil
Imiquimod
Melatonin
Sponsored by
Ismail Gögenur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

No Intervention

Arm Label

5-Fluorouracil

Imiquimod

Melatonin

Control

Arm 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.

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.

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.

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

Outcomes

Primary Outcome Measures

Gene and protein expression profiles

Secondary Outcome Measures

histopathological assessment of actinic keratoses

Full Information

First Posted
February 3, 2023
Last Updated
February 13, 2023
Sponsor
Ismail Gögenur
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1. Study Identification

Unique Protocol Identification Number
NCT05740969
Brief Title
Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
Acronym
PACKS
Official Title
Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ismail Gögenur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5-Fluorouracil
Arm Type
Active Comparator
Arm 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.
Arm Title
Imiquimod
Arm Type
Active Comparator
Arm 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.
Arm Title
Melatonin
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary.
Intervention Type
Drug
Intervention Name(s)
5Fluorouracil
Intervention Description
Cream
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
Cream
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Cream
Primary Outcome Measure Information:
Title
Gene and protein expression profiles
Time Frame
10 days of treatment
Secondary Outcome Measure Information:
Title
histopathological assessment of actinic keratoses
Time Frame
10 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jawad A Zahid, MD
Phone
+4551329815
Email
jaza@regsj.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail A. Gögenur, MD, DMSc
Organizational Affiliation
Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Roskilde
State/Province
Region Sjælland
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jawad A Zahid, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

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