Clinical trial · Interventional
IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis
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
NCT02281682CI-TRIAL-00030121AktiunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Imiquimod | Drug | Imiquimod | ALIAS |
| Ingenol mebutate | Drug | — | UNRESOLVED |
| methylaminolevulinate photodynamic therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Imiquimod
- description
- three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
- interventionNames
- Drug: 5-fluorouracil
- Drug: Ingenol mebutate
- Procedure: methylaminolevulinate photodynamic therapy
- type
- ACTIVE_COMPARATOR
- label
- 5-Fluorouracil
- description
- during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
- interventionNames
- Drug: Imiquimod
- Drug: Ingenol mebutate
- Procedure: methylaminolevulinate photodynamic therapy
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDAhmady S, Jansen MHE, Nelemans PJ, Kessels JPHM, Arits AHMM, de Rooij MJM, Essers BAB, Quaedvlieg PJF, Kelleners-Smeets NWJ, Mosterd K. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022 Jun 1;158(6):634-640. doi: 10.1001/jamadermatol.2022.1034. PMID 35475852
- DERIVEDAhmady S, Jansen MHE, Nelemans PJ, Essers BAB, Kessels JPHM, Kelleners-Smeets NWJ, Mosterd K. The Effect of Four Approaches to Treat Actinic Keratosis on the Health-Related QOL, as Assessed by the Skindex-29 and Actinic Keratosis QOL. J Invest Dermatol. 2021 Jul;141(7):1830-1832. doi: 10.1016/j.jid.2020.12.023. Epub 2021 Jan 18. No abstract available. PMID 33476658
- DERIVEDJansen MHE, Kessels JPHM, Merks I, Nelemans PJ, Kelleners-Smeets NWJ, Mosterd K, Essers BAB. A trial-based cost-effectiveness analysis of topical 5-fluorouracil vs. imiquimod vs. ingenol mebutate vs. methyl aminolaevulinate conventional photodynamic therapy for the treatment of actinic keratosis in the head and neck area performed in the Netherlands. Br J Dermatol. 2020 Oct;183(4):738-744. doi: 10.1111/bjd.18884. Epub 2020 Feb 19. PMID 31961446
- DERIVEDJansen MHE, Kessels JPHM, Nelemans PJ, Kouloubis N, Arits AHMM, van Pelt HPA, Quaedvlieg PJF, Essers BAB, Steijlen PM, Kelleners-Smeets NWJ, Mosterd K. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019 Mar 7;380(10):935-946. doi: 10.1056/NEJMoa1811850. PMID 30855743