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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

There is limited quality research on the effectiveness of treatments in Bowen's disease (BD). Patient and lesion characteristics, patient preferences and costs should be considered when choosing therapy. Surgical excision (SE), photodynamic therapy (PDT) and 5-fluorouracil (5FU) are mentioned as treatment options in guidelines. However no clear and evidence based recommendations are made in terms of effectiveness.

Objective: The aim of this study is 1) to evaluate the (cost)effectiveness of 5FU and PDT compared to SE in BD and 2) to compare the effectiveness of 5FU with that of PDT. With a better understanding of the (cost)effectiveness of alternative treatment options, the investigators will supply the necessary evidence for national and international guidelines, to achieve more uniformity in treatment of BD.

Study design: Randomized controlled non-inferiority multicenter trial. Study population:

Patients ≥18 years, with a histological proven primary lesion of Bowen's disease, visiting Maastricht University Medical Centre, Catharina hospital Eindhoven, VieCuri MC Venlo or Zuyderland Medical Centre Heerlen.

Intervention: One group undergoes SE with a 5mm safety margin followed by routine histological examination. The other group receives PDT with application of methyl aminolevulinate (MAL) cream followed by two illuminations with a one-week interval. The third group receives 5FU cream, which has to be applied by the patient twice daily for 4 weeks.

Main study parameters/endpoints: The primary outcome is the proportion of patients with sustained clearance at 12 months post-treatment. Secondary outcomes are proportion of patients with clearance at 3 months, 3-year and 5-year probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome. Post-treatment, patients will be asked to answer a short questionnaire regarding side effects, experience with the treatment and satisfaction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Aminolevulinic Acid; Fluorouracil; Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

• Adults ≥ 18 years

• Histologically proven primary Bowen's disease

• Lesions ≥ 4mm and ≤ 40mm in diameter

• Fitzpatrick skin type I-IV

• Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment

Exclusion Criteria:

• Bowen's Disease located at ears, periocular, nail unit or periungual tissue, nose, genital and mucous membranes

• High clinical suspicion of invasive SCC

• Interfering treatment of other (N)MSC in target area

• Not able to self-apply cream on lesions located on the back or other difficult to reach locations

• Pregnancy

• Breastfeeding

• Allergy to study drugs

• Genetic skin cancer disorders

• Not understanding Dutch language

• Porphyria

• Not able to give informed consent

• Immuno-compromised status

• Use of systemic retinoid in the past 3 months

• Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, in-terferon, opioids, TNF binding proteins, MMF, biologic agents). Inhalation corticoster-oids / nasal corticosteroids are permitted.