Clinical trial NCT02878382: Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
Official title: Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratosis
Keywords: PDT
skin cancer
calcipotriol
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Changes From Baseline in Actinic Keratosis - Lesion Base Count.
timeFrame: Change from baseline, 90 days, 180 days and 12 months after the PDT
measure: Percentage of Actinic Keratosis (AK) Lesions Cleared
timeFrame: Change from baseline, 90 days, 6 months and 12 months after PDT
Secondary outcomes:
measure: Pain Scores Immediately Post Illumination
timeFrame: immediately after intervention
measure: Change From Baseline in Fluorescence Intensity of PPIX
timeFrame: Baseline and 10 minutes after illumination
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade de Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Universidade Sao Paulo
state: SP
Study officials:
affiliation: Hospital das Clinicas FMUSP Sao Paulo
name: Luis A Torezan, MD
role: PRINCIPAL_INVESTIGATOR
References: