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

NCT03990636 | Unknown Phase 2 DMC

• 1 other identifier: INCABrazilCOPQ
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Actinic Cheilitis; Leukoplakia; Erythroplakia

Keywords

PDT; Actinic Cheilitis; Phase 2 Clinical Trial

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• IHC analysis

  18 months

Study Arms (2)

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

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; Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Histopathological diagnosis of squamous cell carcinoma (SCC)
• Patient presenting any type of immunosupression
• Recurrent crust of the lip vermilion (high risk of SCC)

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

MeSH Terms

Conditions

Actinic cheilitis; Leukoplakia; Erythroplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Cohen Goldemberg, PhD

CONTACT

+5521988167978; daniel.cohen@inca.gov.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: October 17, 2019
• Primary Completion: May 15, 2020
• Study Completion: December 15, 2021
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share