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

Condition(s) targeted: Keratosis, Actinic

Intervention: Imiquimod (Drug); 5-fluorouracil (Drug); Ingenol mebutate (Drug); methylaminolevulinate photodynamic therapy (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
Klara Mosterd, MD, PhD, Principal Investigator, Affiliation: Maastricht University Hospital

Overall contact:
Nina Kouloubis, MD, Phone: 0031433875290, Email: nina.kouloubis@mumc.nl

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.

Official title: Topical Ingenol Mebutate Versus 5% 5-fluorouracil Versus 5% Imiquimod Versus Photodynamic Therapy in Treatment of Actinic Keratosis: a Multi-centre Randomized Efficacy and Cost-effectiveness Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: treatment succes

Secondary outcome:

treatment failure

Treatment succes at 3 months post treatment

complete lesion clearance

SCC

side effects

Cosmetic outcome

patient satisfaction

treatment compliance

Overall decrease in AK

Cost-effectiveness

Investigator Global Improvement Indices

Number of new lesions

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 skin condition. It can transform into squamous cell carcinoma (SCC). AK's generally arise in a skin area that has diffuse precancerous damage, a phenomenon called field cancerization. Because of its precancerous character, it is advised to treat AK and herewith prevent development into SCC. The most frequently used field-directed treatments in the Netherlands are photodynamic therapy (PDT), topical 5% f-fluorouracil (5% 5-FU) and topical 5% Imiquimod (5% IMI). Lately another topical product is approved by Dutch healthcare insurances: Ingenol mebutate (IM). Up to date, which treatment the patient will receive, does not rely on evidence-based-medicine, but generally on the preference of the physician. Current national and international guidelines state no clear recommendations for the best choice of therapy. The aim of this study determine which treatment is the most effective treatment in terms of lesion reduction, costs and patient satisfaction when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel, in treatment of actinic keratosis (AK).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

Nina Kouloubis, MD, Phone: 0031433875290, Email: nina.kouloubis@mumc.nl

Maastricht UMC, Maastricht, Limburg 6202 AZ, Netherlands; Recruiting
Nina Kouloubis, MD, Phone: + 31 (0) 43 3877293, Email: nina.kouloubis@mumc.nl
Janneke Kessels, MD, Phone: + 31 (0) 43 3877293, Email: janneke.kessels@mumc.nl

Starting date: January 2015
Last updated: January 22, 2015