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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990636
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Cohen Goldenberg, Instituto Nacional de Cancer, Brazil

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Actinic Cheilitis Leukoplakia Erythroplakia Drug: Metil 5-aminolevulinate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
Estimated Study Start Date : October 17, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : December 15, 2021

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Complete clinical response [ Time Frame: 18 months ]
    Expected complete clinical response in 60% of cases

  2. Histological cure [ Time Frame: 18 months ]
    Expected histological cure in 40% of cases


Secondary Outcome Measures :
  1. IHC analysis [ Time Frame: 18 months ]
    Expression of immunohistochemical markers of cancer progression


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990636


Contacts
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Contact: Daniel Cohen Goldemberg, PhD +5521988167978 daniel.cohen@inca.gov.br

Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
More Information
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Responsible Party: Daniel Cohen Goldenberg, Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT03990636    
Other Study ID Numbers: INCABrazilCOPQ
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by Daniel Cohen Goldenberg, Instituto Nacional de Cancer, Brazil:
PDT
Actinic Cheilitis
Phase 2 Clinical Trial
Additional relevant MeSH terms:
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Leukoplakia
Cheilitis
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
Lip Diseases
 Mouth Diseases
Stomatognathic Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents