Comparative study for the treatment of actinic keratosis: 5% fluorouracil versus Imiquimod versus photodynamic therapy versus ingenol mebutate.

Phase 1

• Conditions: Actinic keratosis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-003691-23-NL
• Lead Sponsor: Maastricht Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 624

Inclusion Criteria

-Patients older than 18 years
- Female in child bearing potential should be using contraceptive measures,
during and till 3 months post-treatment
-Fitzpatrick skintype I-IV
-Clinically confirmed diagnosis of AK
-One joint area of minimal 25 cm2 and maximal 100 cm2 of AK
-AK Olsen grade I-III
-Location: head/neck area
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 312
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 312

Exclusion Criteria

-Received any kind of treatment for AK in the past 3 months
-(N)MSC in target area
-Immuno-comprised status
-Use of immunosuppressant drugs in the past 3 months and / or at time of
treatment (inhalation corticosteroids / nasal corticosteroids are permitted)
-Porphyria
-Not able to give informed consent
-Allergy to study drugs or nut/soy products
-Pregnant and breastfeeding women
-Genetic skin cancer disorders
- No understanding of dutch language

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified