Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial (PDTMALAC)

June 17, 2019 updated by: Daniel Cohen Goldenberg, Instituto Nacional de Cancer, Brazil

Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial

Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis with histopathological confirmation of actinic cheilitis
  • Patients will be requested to respect the timeframe of clinical consultations
  • No treatment for actinic cheilitis in the last 3 months

Exclusion Criteria:

  • Histopathological diagnosis of squamous cell carcinoma (SCC)
  • Patient presenting any type of immunosupression
  • Recurrent crust of the lip vermilion (high risk of SCC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metil 5-aminolevulinate arm
Metil 5-aminolevulinate arm with photo activation.
Drug: Metil 5-aminolevulinate
Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.
Placebo Comparator: Placebo arm
Placebo (without metil 5-aminolevulinate) arm with photo activation.
Drug: Metil 5-aminolevulinate
Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete clinical response
Time Frame: 18 months
Expected complete clinical response in 60% of cases
18 months
Histological cure
Time Frame: 18 months
Expected histological cure in 40% of cases
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IHC analysis
Time Frame: 18 months
Expression of immunohistochemical markers of cancer progression
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 17, 2019

Primary Completion (Anticipated)

May 15, 2020

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCABrazilCOPQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The Informed Consent Form (ICF) will be read and explained to each patient informing about all the risks and potential benefits. Clinical Study Report (CSR) is going to be registered for all patients, although data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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