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

Sponsor

Instituto Nacional de Cancer, Brazil (Other)

Overall Status

Unknown status

CT.gov ID

NCT03990636

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Cheilitis Leukoplakia Erythroplakia	Drug: Metil 5-aminolevulinate	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 17, 2019

Anticipated Primary Completion Date :

May 15, 2020

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metil 5-aminolevulinate arm Metil 5-aminolevulinate arm with photo activation.	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.
Placebo Comparator: Placebo arm Placebo (without metil 5-aminolevulinate) arm with photo activation.	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.

Arm

Intervention/Treatment

Experimental: Metil 5-aminolevulinate arm

Metil 5-aminolevulinate arm with photo activation.

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.

Placebo Comparator: Placebo arm

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

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Instituto Nacional de Cancer, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Cohen Goldenberg, Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis, Instituto Nacional de Cancer, Brazil

ClinicalTrials.gov Identifier:

NCT03990636

Other Study ID Numbers:

INCABrazilCOPQ

First Posted:

Jun 19, 2019

Last Update Posted:

Jun 19, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Daniel Cohen Goldenberg, Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis, Instituto Nacional de Cancer, Brazil

PDT

Actinic Cheilitis

Phase 2 Clinical Trial

Additional relevant MeSH terms:

Leukoplakia

Cheilitis

Aminolevulinic Acid

Study Results

No Results Posted as of Jun 19, 2019