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

Instituto Nacional de Cancer, Brazil

Status and phase: Unknown; Phase 2

Conditions: Actinic Cheilitis; Leukoplakia; Erythroplakia

Treatments: Drug: Metil 5-aminolevulinate

Study type: Interventional

Funder types: Other

Identifiers

NCT03990636

INCABrazilCOPQ

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Metil 5-aminolevulinate arm

Experimental group

Description:

Metil 5-aminolevulinate arm with photo activation.

Treatment:

Drug: Metil 5-aminolevulinate

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Metil 5-aminolevulinate