New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)

Study Overview
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Brief Summary
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Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification. This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart. Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.

Official Title
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A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.

Conditions
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Skin Neoplasms, Carcinoma, Basal Cell

Intervention / Treatment
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* Drug: MAL-PDT re-treatment
* Drug: usual MAL-PDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male/female above 18 years of age written informed consent 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type Exclusion Criteria: pregnancy breastfeeding Gorlin's syndrome porphyria xeroderma pigmentosum history of arsenic exposure known allergy to MAL concomitant treatment with immunosuppressive medication physical or mental conditions that most likely will prevent patients attending follow-up sessions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAL-PDT re-treatment<br>1 treatment of MAL-PDT with re-treatment of non-complete responders | Drug: MAL-PDT re-treatment<br>* a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months<br>* Other names: Methyl-aminolevulinate;|
| Active Comparator: usual MAL-PDT<br>2 MAL-PDT treatments 1 week apart | Drug: usual MAL-PDT<br>* schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.<br>* Other names: Methyl-aminolevulinate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesions response rate | Number of lesions in clinical complete response at follow-up | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photochemotherapy, methyl 5-aminolevulinate