Status:
UNKNOWN
IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Keratosis, Actinic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatmen...
Detailed Description
Skin cancer is the most common cancer in Caucasians and therefore a major public health issue. Its incidence is increasing rapidly. Actinic keratosis (AK) is the most prevalent precancerous chronic sk...
Eligibility Criteria
Inclusion
- Patients older than 18 years
- Fitzpatrick skintype I-IV
- Clinically confirmed diagnosis of AK
- One joint area of minimal 25 cm2 and maximal 100 cm2 of AK
- Minimum of 5 AK lesions
- AK Olsen grade I-III
- Location: head/neck area
Exclusion
- Received any kind of treatment for AK in the past 3 months
- (non)melanoma skin cancer in target area
- Immuno-compromised status
- Use of systemic retinoid in the past 3 months
- Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, interferon, opioids, Tumor Necrosis Factor (TNF) binding proteins, mycofenolate mofetil (MMF), biologic agents). inhalation corticosteroids / nasal corticosteroids are permitted.
- Porphyria
- Not able to give informed consent
- Allergy to study drugs or peanut/nut/soy products
- Pregnant and breastfeeding women
- Female in child bearing potential not using contraceptive measures, during and till 3 months post-treatment
- Genetic skin cancer disorders
- Not understanding Dutch language
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT02281682
Start Date
November 1 2014
End Date
December 1 2018
Last Update
October 30 2017
Active Locations (1)
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1
Maastricht UMC
Maastricht, Limburg, Netherlands, 6202 AZ