Does 4% 5-fluorouracil pre-treatment improve the efficacy of daylight photodynamic therapy for actinic keratoses – a randomized controlled study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001586-21-DK

Enrollment

Registered

2021-04-13

Start date

2021-09-22

Completion date

Unknown

Last updated

2024-01-15

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

Conditions

Actinic keratosis MedDRA version: 21.1 Level: LLT Classification code 10041304 Term: Solar keratosis System Organ Class: 100000004858

Interventions

Trade Name: Tolak Pharmaceutical Form: Cream INN or Proposed INN: 5-fluorouracil Other descriptive name: FLUOROURACIL Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients above 18 years of age - Clinically assessed = 5 AK in two symmetrical areas of the face or scalp - Female subjects of childbearing potential must be confirmed not pregnant by negative pregnancy test prior to study inclusion and must use a safe contraceptive method during the study - Signed informed consent 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: - Concomitant treatment with immunosuppressant drugs - Any AK treatment within the areas for 3 months before treatment - Known porphyria - Allergy to trial drugs - Peanut or soya allergy - Pregnant or breast-feeding women

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare the efficacy of sequential 4% 5-FU and daylight MAL-PDT with daylight MAL-PDT alone in the treatment of multiple actinic keratoses in the face and scalp;Secondary Objective: - Remaining complete lesion response rate at 6 months and 12 months after treatment - Number of new AK lesions at 6 and 12 months after treatment - Adverse effects before PDT and 2-4 days after PDT - Association between illuminance/effective light dose and efficacy - Association between light exposure modality (indoor or ambient) and efficacy - Treatment induced changes in AK lesions detected by OCT;Primary end point(s): Complete lesion response rate after 5-fluorouracil + daylight PDT compared with daylight PDT alone;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: The aim of the study is to compare the efficacy of sequential 4% 5-FU and daylight MAL-PDT with daylight MAL-PDT alone in the treatment of multiple actinic keratoses in the face and scalp;Secondary Objective: - Remaining complete lesion response rate at 6 months and 12 months after treatment - Number of new AK lesions at 6 and 12 months after treatment - Adverse effects before PDT and 2-4 days after PDT - Association between illuminance/effective light dose and efficacy - Association between light exposure modality (indoor or ambient) and efficacy - Treatment induced changes in AK lesions detected by OCT;Primary end point(s): Complete lesion response rate after 5-fluorouracil + daylight PDT compared with daylight PDT alone;Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Remaining complete lesion response rate - Number of new AK lesions;Timepoint(s) of evaluation of this end point: 6 and 12 months	—

Countries

Denmark

Contacts

Public ContactPrincipal investigator

Bispebjerg Hospital, Department of Dermatology

stine.regin.wiegell@regionh.dk

Outcome results

None listed

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