Surgical excision versus photodynamic therapy and topical 5-fluorouracil in treatment of Bowen*s disease: a multicenter randomized controlled trial

Phase 4

Recruiting

Conditions: Bowen's disease
squamous cell carcinoma in situ
10040900
10040795

Registration Number: NL-OMON49810

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 250

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 , nail unit or periungual
tissue, nose (limited light exposure for PDT), genital and mucous membranes
(different entities)
-High clinical suspicion of invasive SCC
-Interfering treatment of other (N)MSC in target area
-Breastfeeding
-Pregnancy
-Allergy to study drugs
-Not able to self-apply cream on lesions located on the back or other difficult
to reach locations
-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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the proportion of patients with sustained clearance<br /><br>(no residue, recurrence or progression) 12 months post-treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: the proportion of patients with clearance at 3 months<br /><br>post-treatment, long-term probability of sustained clearance,<br /><br>cost-effectiveness, patient satisfaction, patient preferences, compliance,<br /><br>side effects and cosmetic outcome.</p><br>