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Clinical Trials/EUCTR2021-005996-37-DK
EUCTR2021-005996-37-DK
Active, not recruiting
Phase 1

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

Zealand University Hospital0 sites60 target enrollmentJanuary 18, 2022
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ConditionsActinic keratosesMedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsTolakAldara

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Actinic keratoses
Sponsor
Zealand University Hospital
Enrollment
60
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 18, 2022
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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