Bowen's disease squamous cell carcinoma in situ
Conditions
Interventions
Surgical excision (SE)
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 s
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Adults >= 18 years -Histologically proven primary Bowen*s disease -Lesions >= 4mm and
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the proportion of patients with sustained clearance (no residue, recurrence or progression) 12 months post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: the proportion of patients with clearance at 3 months post-treatment, long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome. | — |
Countries
Netherlands
Outcome results
None listed