Comparative study for the treatment of actinic keratosis: 5% fluorouracil versus Imiquimod versus photodynamic therapy versus ingenol mebutate.

Topical Ingenol mebutate versus 5% 5-fluorouracil versus 5% Imiquimod versus photodynamic therapy in the treatment of actinic keratosis: a multi-center randomized efficacy and cost-effectiveness study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003691-23-NL

Enrollment

624

Registered

2014-09-30

Start date

2014-11-10

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis

Interventions

Trade Name: Ingenol mebutate (Picato) Pharmaceutical Form: Cream Trade Name: 5% Imiquimod (Aldara) Product Name: Aldara Product Code: E

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 312 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 312

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary 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 Objective: - 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 SCC’s developing in the treatment area, during study follow-up, and long-term follow-up. - Healthcare/treatment costs - Side effects - Patient satisfaction - Cosmetic outcome - Treatment compliance ;Primary end point(s): Primary endpoint: 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;Timepoint(s) of evaluation of this end point: 12 months post-treatment	—

Measure

Time frame

Main Objective: Primary 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 Objective: - 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 SCC’s developing in the treatment area, during study follow-up, and long-term follow-up. - Healthcare/treatment costs - Side effects - Patient satisfaction - Cosmetic outcome - Treatment compliance ;Primary end point(s): Primary endpoint: 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;Timepoint(s) of evaluation of this end point: 12 months post-treatment

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Secondary

Measure	Time frame
Secondary end point(s): - 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 SCC’s developing in the treatment area during study follow-up, and long-term follow-up. - Healthcare/treatment costs - Side effects - Patient satisfaction - Cosmetic outcome - Treatment compliance ; Timepoint(s) of evaluation of this end point: 12 months post treatment The number of SCC in the treatment area 12 months post treatment and long-term (2- to 5-years) post study treatment	—

Measure

Time frame

Secondary end point(s): - 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 SCC’s developing in the treatment area during study follow-up, and long-term follow-up. - Healthcare/treatment costs - Side effects - Patient satisfaction - Cosmetic outcome - Treatment compliance ; Timepoint(s) of evaluation of this end point: 12 months post treatment The number of SCC in the treatment area 12 months post treatment and long-term (2- to 5-years) post study treatment

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Countries

Netherlands

Contacts

Public ContactShima Ahmady

Maastricht University Medical Center

shima.ahmady@mumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026