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

NCT03990636 — Phase 2, Unknown, 40 participants, Instituto Nacional de Cancer, Brazil

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

Registry	NCT03990636, acronym PDTMALAC
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	40 (Estimated)
Sponsor	Instituto Nacional de Cancer, Brazil (Other gov)
Conditions	Actinic Cheilitis, Leukoplakia, Erythroplakia
Interventions	Metil 5-aminolevulinate (Drug)
Dates	start 2019-10-17 (estimated), primary completion 2020-05-15 (estimated), completion 2021-12-15 (estimated), first posted 2019-06-19, last updated 2019-06-19

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Metil 5-aminolevulinate arm	Experimental	Drug: Metil 5-aminolevulinate	Metil 5-aminolevulinate arm with photo activation.
Placebo arm	Placebo comparator	Drug: Metil 5-aminolevulinate	Placebo (without metil 5-aminolevulinate) arm with photo activation.

Metil 5-aminolevulinate (Drug): Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.

+Outcome measures

Primary outcomes

Complete clinical response [18 months]: Expected complete clinical response in 60% of cases
Histological cure [18 months]: Expected histological cure in 40% of cases

Secondary outcomes

IHC analysis [18 months]: Expression of immunohistochemical markers of cancer progression

+Eligibility

Sex: All, ages: 18 Years to any

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)

My Notes

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