Gene and protein expression after treatment of actinic keratosis

Gene and protein expression profiles after treatment of actinic keratosis - PACKS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005996-37-DK

Enrollment

Registered

2022-01-18

Start date

2022-01-18

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratoses MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Melatonin Pharmaceutical Form: Cream INN or Proposed INN: Melatonin CAS Number: 73-31-4 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 25- Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants should a clinical diagnosis of actinic keratosis 2. Participants should be above 18 years old 3. Participants must sign an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Known allergic reaction to either 5-flurourocil, imiquimod, or melatonin 2. Immunomodulating treatment 3. Predictable poor compliance (due to i.e. dementia, substance abuse, psychiatric disease, life-threatening disease or language barriers) 4. Pregnant or breastfeeding 5. 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to investigate the effect on the immunological gene and protein expression of different current and experimental treatment options for actinic keratosis.;Secondary Objective: Secondarily the objective is to assess the effect of the treatments on a histopathological level. ;Primary end point(s): Differences in gene and protein expression in the actinic keratoses;Timepoint(s) of evaluation of this end point: In treatment arm after 14 days and in control arm on day 0.	—

Measure

Time frame

Main Objective: The primary objective of the study is to investigate the effect on the immunological gene and protein expression of different current and experimental treatment options for actinic keratosis.;Secondary Objective: Secondarily the objective is to assess the effect of the treatments on a histopathological level. ;Primary end point(s): Differences in gene and protein expression in the actinic keratoses;Timepoint(s) of evaluation of this end point: In treatment arm after 14 days and in control arm on day 0.

—

Secondary

Measure	Time frame
Secondary end point(s): Histopathological assessment of the actinic keratoses;Timepoint(s) of evaluation of this end point: In treatment arm after 14 days and in control arm on day 0	—

Countries

Denmark

Contacts

Public ContactCenter For Surgical Science

Zealand University Hospital

jaza@reiognsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026