Keratosis, Actinic Clinical Trial
— AktiOfficial 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
Verified date | October 2017 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 624 |
Est. completion date | December 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht UMC | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | treatment succes | the proportion of patients with =75% lesion reduction in the number of AK lesions counted at baseline in the treatment area 12 months post final treatment (= 75% patient clearance at 12 months). | 12 months | |
Secondary | treatment failure | proportion of participants with <75% reduction in number of AK lesions after 3 and 12 months post final treatment compared to baseline (<75% patient clearance at 3 and 12 months). | 12 months | |
Secondary | Treatment succes at 3 months post treatment | proportion of participants with =75% reduction in number of AK lesions at 3 months post final treatment (= 75% patient clearance at 3 months). | 3 months | |
Secondary | complete lesion clearance | proportion of lesions with 100% clearance in all treated patients at 3 and 12 months post final treatment. | 12 months | |
Secondary | SCC | Proportion of patients who develop a SCC in the treatment area during study follow-up. | 12 months | |
Secondary | side effects | local skin reactions reported in patient diary, visual analogue score (VAS), Patient-reported adverse events | 12 months | |
Secondary | Cosmetic outcome | based on a Cosmetic questionnaire, filled in on baseline, 3 + 12 months | 3 and 12 months | |
Secondary | patient satisfaction | Skindex-29 questionnaire (quality of life) , Actinic Keratosis Quality of Life (AKQoL) questionnaire; filled in on baseline, 3 + 12 months | 12 months | |
Secondary | treatment compliance | defined as the number of applied treatments as percentage of the number of prescribed treatments, based on patient diaries and weighing returned medication. | 3 months | |
Secondary | Overall decrease in AK | Decrease in number AK from baseline per patient, at 3 and 12 months post final treatment. | 3 and 12 months | |
Secondary | Cost-effectiveness | Healthcare/treatment costs | 12 months | |
Secondary | Investigator Global Improvement Indices | Investigator Global Improvement Indices (IGII) at 3 and 12 months post final treatment. | 3 and 12 months | |
Secondary | Number of new lesions | Number of new lesions at 3 and 12 months post final treatment | 3 and 12 months |
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