Photodynamic Therapy With Metil 5-aminolevulinate for Act... | NCT03990636

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

NCT03990636

Sponsor

Instituto Nacional de Cancer, Brazil

Status

Unknown status

Last Update Posted

Jun 19, 2019Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Actinic Cheilitis
Leukoplakia
Erythroplakia

Interventions

Metil 5-aminolevulinate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2019Estimated

Primary Completion Date

May 15, 2020Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Jun 17, 2019

First Submission Date that Met QC Criteria

Jun 17, 2019

First Posted Date

Jun 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2019

Last Update Posted Date

Jun 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Instituto Nacional de Cancer, BrazilOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metil 5-aminolevulinate arm	Experimental	Metil 5-aminolevulinate arm with photo activation.	Drug: Metil 5-aminolevulinate
Placebo arm	Placebo Comparator	Placebo (without metil 5-aminolevulinate) arm with photo activation.	Drug: Metil 5-aminolevulinate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Metil 5-aminolevulinate arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete clinical response	Expected complete clinical response in 60% of cases	18 months
Histological cure	Expected histological cure in 40% of cases	18 months

Secondary Outcomes

Measure	Description	Time Frame
IHC analysis	Expression of immunohistochemical markers of cancer progression	18 months

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Cohen Goldemberg, PhD	Contact	+5521988167978		daniel.cohen@inca.gov.br

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C535669	Actinic cheilitis
D007971	Leukoplakia
D004919	Erythroplasia

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided