Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
NCT ID: NCT03990636
Last Updated: 2019-06-19
Study Results
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2019-10-17
2021-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Metil 5-aminolevulinate arm
Metil 5-aminolevulinate arm with photo activation.
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 arm
Placebo (without metil 5-aminolevulinate) arm with photo activation.
Metil 5-aminolevulinate
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.
Eligibility Criteria
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Inclusion Criteria
* Patients will be requested to respect the timeframe of clinical consultations
* No treatment for actinic cheilitis in the last 3 months
Exclusion Criteria
* Patient presenting any type of immunosupression
* Recurrent crust of the lip vermilion (high risk of SCC)
18 Years
ALL
No
Sponsors
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Instituto Nacional de Cancer, Brazil
OTHER_GOV
Responsible Party
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Daniel Cohen Goldenberg
Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis
Central Contacts
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Other Identifiers
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INCABrazilCOPQ
Identifier Type: -
Identifier Source: org_study_id
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