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5-flourouracil treatment prior to photodynamic therapy of precursors to skin cancer on the hands

5-flourouracil treatment prior to photodynamic therapy of actinic keratosis on the hands

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-003003-29-DK
Enrollment
Unknown
Registered
2015-07-09
Start date
2015-08-31
Completion date
Unknown
Last updated
2016-04-11

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

Conditions

Actinic keratosis MedDRA version: 18.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream INN or Proposed INN: Methyl aminolevulinate Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit: mg/g milligram(s)/gram Concen

Sponsors

Department of Dermatology D92, Bispebjerg Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Actinic keratosis on the hands 18 years or older Informed written and oral consent No nevi, tatoos or scars in the treated area Fertile women have to use safe contraceptive measures 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Allergy to the constituents of the used medication (Metvix/Efudix) Concurrent treatment with antiviral nucleoside drugs Pregnancy or breastfeeding Organtransplanted patients Patients with known hypersensitivity to sunlight Patients not believed to be able to follow protocol

Design outcomes

Primary

MeasureTime frame
Main Objective: Investigate if treatment with 5-fluorouracil prior to photodýnamic therapy improves efficacy when treating actinic keratosis on the hands;Secondary Objective: Investigate adverse effects: Pain, erythema, cosmetic outcome;Primary end point(s): Clearance rate 3 months after treatment. It is assessed whether each lesion is completely disappeared after treatment (complete response) or not completely disapperared (non-complete response);Timepoint(s) of evaluation of this end point: 3 months—

Secondary

MeasureTime frame
Secondary end point(s): Investigate adverse effects: Pain, erythema, cosmetic outcome;Timepoint(s) of evaluation of this end point: Pain: during treatment Erythema: 1-2 days after treatment Cosmetic outcome: 3 months after treatment—

Countries

Denmark

Contacts

Public ContactDepartment of Dermatology, D92

Bispebjerg Hospital

hans.christian.olsen.wulf@regionh.dk

Outcome results

None listed

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