N/A Completed N=40 Randomized Single-blind Treatment

Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT

Source: ClinicalTrials.gov NCT02878382 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcomePrimary: Changes From Baseline in Actinic Keratosis - Lesion Base Count. — 1.15; 2.65; 1.15; 2.60 lesions — p=<0.001

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes From Baseline in Actinic Keratosis - Lesion Base Count.	1.15; 2.65; 1.15; 2.60; 1.35; 3.20	<0.001 sig
PRIMARY Percentage of Actinic Keratosis (AK) Lesions Cleared	92.1; 82; 92.1; 81.7; 90.7; 77.5	—
SECONDARY Pain Scores Immediately Post Illumination	5.4; 4.0	=0.001 sig
SECONDARY Change From Baseline in Fluorescence Intensity of PPIX	3422.85; 2688.35	=0.048 sig

Eligibility Criteria

Inclusion Criteria

male gender
at least six AKs per field

Exclusion Criteria

history of photosensitivity related disorders
active infectious disease,
immunosuppression
laser or any cosmetic treatment in the previous 6 months
other topical agents in the treatment area such as retinoids, 5-fluorouracil,imiquimod or diclofenac sodium in the previous 3 months
allergy to MAL or excipients of the cream
poor patient compliance.

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Data sourced from ClinicalTrials.gov (NCT02878382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.