Back to resultsPhotodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial (PDTMALAC)
Primary Purpose
Actinic Cheilitis, Leukoplakia, Erythroplakia
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metil 5-aminolevulinate
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Cheilitis focused on measuring PDT, Actinic Cheilitis, Phase 2 Clinical Trial
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metil 5-aminolevulinate arm
Placebo arm
Arm Description
Metil 5-aminolevulinate arm with photo activation.
Placebo (without metil 5-aminolevulinate) arm with photo activation.
Outcomes
Primary Outcome Measures
Complete clinical response
Expected complete clinical response in 60% of cases
Histological cure
Expected histological cure in 40% of cases
Secondary Outcome Measures
IHC analysis
Expression of immunohistochemical markers of cancer progression
Full Information
NCT ID
NCT03990636
First Posted
June 17, 2019
Last Updated
June 17, 2019
Sponsor
Instituto Nacional de Cancer, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT03990636
Brief Title
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
Acronym
PDTMALAC
Official Title
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2019 (Anticipated)
Primary Completion Date
May 15, 2020 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancer, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Cheilitis, Leukoplakia, Erythroplakia
Keywords
PDT, Actinic Cheilitis, Phase 2 Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metil 5-aminolevulinate arm
Arm Type
Experimental
Arm Description
Metil 5-aminolevulinate arm with photo activation.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo (without metil 5-aminolevulinate) arm with photo activation.
Intervention Type
Drug
Intervention Name(s)
Metil 5-aminolevulinate
Intervention Description
Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.
Primary Outcome Measure Information:
Title
Complete clinical response
Description
Expected complete clinical response in 60% of cases
Time Frame
18 months
Title
Histological cure
Description
Expected histological cure in 40% of cases
Time Frame
18 months
Secondary Outcome Measure Information:
Title
IHC analysis
Description
Expression of immunohistochemical markers of cancer progression
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Cohen Goldemberg, PhD
Phone
+5521988167978
Email
daniel.cohen@inca.gov.br
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The Informed Consent Form (ICF) will be read and explained to each patient informing about all the risks and potential benefits. Clinical Study Report (CSR) is going to be registered for all patients, although data will not be shared.
Learn more about this trial
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
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