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

Topical Ingenol mebutate versus 5% 5-fluorouracil versus 5% Imiquimod versus photodynamic therapy in treatment of actinic keratosis: a multi-center randomized efficacy and cost-effectiveness study - IM vs 5% 5-FU vs 5% IMI vs PDT in treatment of AK

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50427

Enrollment

624

Registered

2014-09-30

Start date

2014-12-11

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

actinic keratosis solar keratosis

Interventions

5% Imiquimod versus 5% 5-fluorouracil versus Ingenol mebutate versus MAL-photodynamic therapy

Eligibility

Age

18 Years to 99 Years

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 - Minimum of 5 AK lesions within the joint area - AK Olsen grade I-III - Location: head/neck area

Exclusion criteria

Exclusion criteria: - Received any kind of treatment for AK in the past 3 months, except for cryosurgery outside the treatment area. - (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 peanut/nut/soy products - Pregnant and breastfeeding women - Genetic skin cancer disorders - No understanding of dutch language

Design outcomes

Primary

Measure	Time frame
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 final treatment ( 75% patient clearance at 12 months).	—

Secondary

Measure	Time frame
- Treatment failure: proportion of participants with	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)