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Treatment of Actinic keratosis: topical ingenol mebutate versus 5%5-fluorouracil versus 5% imiquimod versus photodynamic therapy.


- candidate number20125
- NTR NumberNTR4849
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2014
- Secondary IDsNL50621.068.14 METC142052
- Public TitleTreatment of Actinic keratosis: topical ingenol mebutate versus 5%5-fluorouracil versus 5% imiquimod versus photodynamic therapy.
- Scientific TitleTopical 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
- ACRONYMAKTI-trial
- hypothesisPrimary outcome is to define the treatment success of four topical treatment modalities for AK. We expect topical 5-flourouracil to be the most cost-effective treatment.
- Healt Condition(s) or Problem(s) studiedActinic keratosis
- 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
- 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jan-2018
- Target number of participants624
- InterventionsIngenol mebutate versus 5% 5-fluorouracil versus 5% imiquimod versus photodynamic therapy
- Primary outcomePrimary outcome measure: treatment success (i.e. the proportion of patients with >75% lesion reduction in the number of AK lesions counted at baseline in the treatment area) 12 months post treatment.
- Secondary outcome- Partial response (proportion of participants at 12 months post treatment with 50-75% reduction in number of AK lesions)
- Treatment failure (proportion of participants at 12 months post treatment with <50% reduction in number of AK lesions)
- Complete lesion clearance (proportion of lesions with 100% clearance in all treated patients per study arm)
- Partial lesion clearance (proportion of lesions with >75% clearance in all treated patients per study arm)
- Decrease in number AK from baseline per patient
- Number of SCCs developing in the treatment area
- Healthcare/treatment costs
- Side effects
- Patient satisfaction
- Cosmetic outcome
- Treatment compliance
- Timepoints3 and 12 months follow-up time
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Kessels
- CONTACT for SCIENTIFIC QUERIES J. Kessels
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale: 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). AKs 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 is to investigate what is the most effective field-directed treatment for AK. Objective: 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 0.015%ingenol mebutate (IM) gel, in treatment of actinic keratosis (AK) Study design: Prospective randomized controlled multi-centre study. Study population: Patients, >18 years, Fitzpatrick skintype I-IV, with an area of minimal 25cm2 and maximal 100 cm2 AK, Olsen grade I-III, localized in the head,- and neck area, visiting Dermatology departments of the Maastricht University Medical Centre (MUMC), Catharina hospital Eindhoven, Atrium Medical Centre Heerlen or VieCuri Medical Centre Venlo. Intervention: PDT versus 5% 5-FU versus 5% IMI versus 0.015% IM. Main study parameters/endpoints: Primary outcome measure is adequate treatment success, defined as the proportion of participants at 12 months post treatment, with 75% reduction in the number of AK lesions counted at baseline in the treatment area. Secondary outcomes: partial response (proportion of participants with 50-75% reduction in number of AK lesions after 12 months compared to baseline), treatment failure (proportion of participants with <50% reduction in number of AK lesions after 12 months compared to baseline), partial lesion clearance (proportion of lesions with 75% clearance), complete lesion clearance (proportion of lesions with 100% clearance in all treated patients), decrease in number AK from baseline per patient, costs, side effects, patient satisfaction, cosmetic outcome and treatment compliance, proportion of patients who develop SCC in treated areas.
- Main changes (audit trail)
- RECORD14-okt-2014 - 8-nov-2014


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