N/A
N=40
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT02878382 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Changes From Baseline in Actinic Keratosis - Lesion Base Count. — 1.15; 2.65; 1.15; 2.60 lesions — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conventional MAL-PDT (Other); Calcipotriol assisted MAL-PDT (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- University of Sao Paulo
- Primary completion
- Jan 2017
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 |
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.
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.
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.