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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.
Details
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2016-10 |
| Completion | 2020-04 |
Conditions
- Actinic Keratosis
Interventions
- Conventional MAL-PDT
- Calcipotriol assisted MAL-PDT
Primary outcomes
- Changes From Baseline in Actinic Keratosis - Lesion Base Count. — Change from baseline, 90 days, 180 days and 12 months after the PDT
To compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp. The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention. Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side. - Percentage of Actinic Keratosis (AK) Lesions Cleared — Change from baseline, 90 days, 6 months and 12 months after PDT
AK clearance after PDT and comparison between the sides The values in the data table represent the percentage of AK clearance on each side at 3, 6 and 12 months post intervention. At baseline: 290 on the CAL-PDT side and 284 on the conventional side.
Countries
Brazil