Actinic Keratosis Clinical Trial
Official title:
Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study
In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing
prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL),
is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).
Reduced response rates are observed in thicker skin lesions, which may be due to insufficient
PpIX accumulation within the target tissue.
To enhance PpIX production,several physical and chemical pretreatments have been suggested.
One of the chemical substances proposed to stimulate PpIX production is vitamin D because of
its ability of being a keratinocyte pro-differentiating hormone.
Based on in vitro and in animal model studies, we propose to study the potential impact of
patient vitamin D pre-treatment in AK response to MAL-PDT.
A randomized, controlled Split -scalp study with Calcipotriol Assisted MAL-PDT versus
conventional MAL-PDT for actinic keratosis (AK) is proposed.
Twenty patients ( male gender only) with symmetrically distributed multiple AK lesions on the
scalp will be included. Patients must have at least five AKs per field to be eligible.
After simple randomization, one half of the scalp will be treated with Calcipotriol ointment
50 mcg/g (Daivonex, Leo Pharma, Denmark) for 15 consecutive days.
After this period, the entire scalp will be submitted to topical PDT with
Methylaminolevulinate 16% (Metvix, Galderma France) under occlusion for 90 minutes and then,
illuminated with a light source consisting of a Light Emitting Diode device (LED) at 635 nm (
Aktilite - Photocure, Norway). The total light dose will be 37J/cm2.
Immediately before and after illumination with LED, measurements of the fluorescence
intensity will be taken in 3 isolated spots in both sides of the scalp with a spectroscopy
deviceUSB 2000+ ( Ocean Optics ® - Dunedin, Fl, USA).
AK lesions will be counted and mapped by a dermatologist not involved in the study before and
after 3 months.
All patients will be advised to apply sunscreens 50 + 3x/day for the following 7 days after
the procedure.
A 0-10 Visual Analogue Scale (VAS) will be used to measure the pain intensity during the
illumination.
Records will be taken after 90 days and compared between sides: side effects, AK lesion
response and pain level intensity. Also, a long term follow up will be provided at 6 and 12
months after.
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