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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990636
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Cohen Goldenberg, Instituto Nacional de Cancer, Brazil

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 19, 2019
Estimated Study Start Date  ICMJE October 17, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Complete clinical response [ Time Frame: 18 months ]
    Expected complete clinical response in 60% of cases
  • Histological cure [ Time Frame: 18 months ]
    Expected histological cure in 40% of cases
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
IHC analysis [ Time Frame: 18 months ]
Expression of immunohistochemical markers of cancer progression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
Official Title  ICMJE Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Actinic Cheilitis
  • Leukoplakia
  • Erythroplakia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Metil 5-aminolevulinate arm
    Metil 5-aminolevulinate arm with photo activation.
    Intervention: Drug: Metil 5-aminolevulinate
  • Placebo Comparator: Placebo arm
    Placebo (without metil 5-aminolevulinate) arm with photo activation.
    Intervention: Drug: Metil 5-aminolevulinate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Cohen Goldemberg, PhD +5521988167978 daniel.cohen@inca.gov.br
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990636
Other Study ID Numbers  ICMJE INCABrazilCOPQ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Daniel Cohen Goldenberg, Instituto Nacional de Cancer, Brazil
Study Sponsor  ICMJE Instituto Nacional de Cancer, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto Nacional de Cancer, Brazil
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP