IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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 treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Aminolevulinic Acid; Fluorouracil; Imiquimod; Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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