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

Leukoplakia Clinical Trial

— PDTMALAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03990636
• Other study ID #: INCABrazilCOPQ
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 17, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: June 2019
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Daniel Cohen Goldemberg, PhD
• Phone: +5521988167978
• Email: daniel.cohen[@]inca.gov.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 15, 2021
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Actinic Cheilitis
• Erythroplakia
• Erythroplasia
• Leukoplakia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clinical response	Expected complete clinical response in 60% of cases	18 months
Primary	Histological cure	Expected histological cure in 40% of cases	18 months
Secondary	IHC analysis	Expression of immunohistochemical markers of cancer progression	18 months