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

NCT03990636 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-06-19

No results posted yet for this study

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.

Conditions

  • Actinic Cheilitis
  • Leukoplakia
  • Erythroplakia

Interventions

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.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2020-05-15
Completion
2021-12-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990636 on ClinicalTrials.gov