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NCT05740969 Clinical Trial

Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Actinic Keratoses Clinical Trial

— PACKS  

Official title:
Gene and Protein Expression Profiles After Treatment of Actinic Keratoses

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05740969
Other study ID # REG-163-2021
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 1, 2023
Est. completion date December 31, 2024

Study information
Verified date February 2023
Source Zealand University Hospital
Contact Jawad A Zahid, MD
Phone +4551329815
Email jaza@regsj.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date December 31, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 5Fluorouracil
Cream
• Imiquimod
Cream
• Melatonin
Cream

Locations
Country Name City State
Denmark Zealand University Hospital Roskilde Region Sjælland

Sponsors (1)
Lead Sponsor Collaborator
Ismail Gögenur

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gene and protein expression profiles 10 days of treatment
Secondary histopathological assessment of actinic keratoses 10 days of treatment
See also
  Status Clinical Trial Phase
Completed NCT03575780 - Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis Phase 1
Completed NCT04085367 - Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face Phase 3
Completed NCT05937529 - Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis N/A
Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
Completed NCT01354717 - Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo Phase 3
Completed NCT00742391 - A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations Phase 3
Completed NCT03285477 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp Phase 3
Suspended NCT03963102 - Duration of Ameluz Application in Acral Actinic Keratoses Response Phase 4
Not yet recruiting NCT05923060 - Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses Phase 2
Withdrawn NCT06026358 - Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Phase 4
Completed NCT02622594 - Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times Phase 4
Completed NCT00786994 - The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses Phase 2
Completed NCT00774787 - Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses Phase 4
Completed NCT00544258 - Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005 Phase 1
Completed NCT04024579 - Treatment of Actinic Keratosis With 5% KOH Solution
Completed NCT04843553 - Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients Early Phase 1
Completed NCT03315286 - Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure N/A
Completed NCT03279328 - Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents Phase 4
Completed NCT02062853 - Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video N/A