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

Phase 1

• Conditions: Actinic keratosis; MedDRA version: 21.1Level: LLTClassification code 10041304Term: Solar keratosisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-001586-21-DK
• Lead Sponsor: Bispebjerg Hospital, Department of Dermatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified