Clinical trial · Interventional
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcipotriol assisted MAL-PDT | Other | — | UNRESOLVED |
| Conventional MAL-PDT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Conventional MAL-PDT
- description
- Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.
- interventionNames
- Other: Conventional MAL-PDT
- type
- OTHER
- label
- Calcipotriol assisted MAL-PDT
- description
- Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT
- interventionNames
- Other: Calcipotriol assisted MAL-PDT
Primary outcomes (2)
- measure
- Changes From Baseline in Actinic Keratosis - Lesion Base Count.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available