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

NCT02878382 | Completed Results DMC

• 1 other identifier: 08/2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Actinic Keratosis

Keywords

PDT; skin cancer; calcipotriol

Outcome Measures

Primary Outcomes (2)

• Changes From Baseline in Actinic Keratosis - Lesion Base Count.

  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.

  Change from baseline, 90 days, 180 days and 12 months after the PDT

• Percentage of Actinic Keratosis (AK) Lesions Cleared

  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.

  Change from baseline, 90 days, 6 months and 12 months after PDT

Secondary Outcomes (2)

• Pain Scores Immediately Post Illumination

  immediately after intervention

• Change From Baseline in Fluorescence Intensity of PPIX

  Baseline and 10 minutes after illumination

Study Arms (2)

Conventional MAL-PDT

OTHER

Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.

Other: Conventional MAL-PDT

Calcipotriol assisted MAL-PDT

OTHER

Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT

Other: Calcipotriol assisted MAL-PDT

Interventions

Conventional MAL-PDT OTHER

Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Conventional MAL-PDT

Calcipotriol assisted MAL-PDT OTHER

Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose

Calcipotriol assisted MAL-PDT

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male gender
• at least six AKs per field

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Universidade de Sao Paulo

São Paulo, São Paulo, 04543120, Brazil

Location

Hospital Das Clinicas Universidade Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Keratosis, Actinic; Skin Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site

Results Point of Contact

• Title: Dr Luis Torezan Associate Professor Dermatology
• Organization: University of Sao Paulo Medical School Brazil

torezanluis@uol.com.br

+551138491888

Study Officials

• Luis A Torezan, MD

  Hospital das Clinicas FMUSP Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 25, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2020
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (2)