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

NCT ID: NCT03990636

Last Updated: 2019-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-17

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Actinic Cheilitis Leukoplakia Erythroplakia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metil 5-aminolevulinate arm

Metil 5-aminolevulinate arm with photo activation.

Group Type EXPERIMENTAL

Metil 5-aminolevulinate

Intervention Type DRUG

Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.

Placebo arm

Placebo (without metil 5-aminolevulinate) arm with photo activation.

Group Type PLACEBO_COMPARATOR

Metil 5-aminolevulinate

Intervention Type DRUG

Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.

Interventions

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Metil 5-aminolevulinate

Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Daniel Cohen Goldenberg

Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Daniel Cohen Goldemberg, PhD

Role: CONTACT

+5521988167978

Other Identifiers

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INCABrazilCOPQ

Identifier Type: -

Identifier Source: org_study_id

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