Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease

PHASE4CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

May 27, 2019

Primary Completion Date

March 2, 2022

Study Completion Date

December 12, 2024

Conditions
Bowen's Disease
Interventions
DRUG

Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram

A layer of methylaminolevulinc acid 160 mg/g cream (about 1 mm thick) is applied to the lesion, with a clinical margin of 5-10 mm surrounding of normal skin and then covered by an occlusive dressing. After 3 hours the occlusive dressing will be removed and the area is illuminated with Omnilux or Actilite (Galderma). After PDT the treatment site is covered again with the above mentioned occlusive dressings during 48 hours. Treatment is performed by an authorized nurse in the hospital. Two sessions should be administered with an interval of one week between sessions.

DRUG

5Fluorouracil

5-FU is applied on the treatment area by the patient in a thin layer twice daily during 4 weeks.

OTHER

Surgical excision

Local anesthesia with lidocain 1% (1-2ml) will be used before performing standard surgical excision with 5 mm safety margin followed by routine histological examination. The skin will be closed using cutaneous sutures, which will be removed after 1-2 weeks. The surgical excision will take place in the hospital by the treating physician

Trial Locations (1)

Unknown

MUMC+, Maastricht

All Listed Sponsors
lead

Maastricht University Medical Center

OTHER

NCT03909646 - Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease | Biotech Hunter | Biotech Hunter