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

Conditions
Actinic keratosis
MedDRA version: 18.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Registration Number
EUCTR2015-003003-29-DK
Lead Sponsor
Department of Dermatology D92, Bispebjerg Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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