Actinic CheilitisPhase 2PDTMALACNCT03990636
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
A Phase 2 study testing Metil 5-aminolevulinate in people with Actinic Cheilitis and Leukoplakia, run by Instituto Nacional de Cancer, Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Cheilitis, Leukoplakia, Erythroplakia
- What is being tested?
- Metil 5-aminolevulinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2019to 15 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Histopathological diagnosis of squamous cell carcinoma (SCC)
- Patient presenting any type of immunosupression
- Recurrent crust of the lip vermilion (high risk of SCC)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
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
- Being tested
- Metil 5-aminolevulinate
- Keywords
- PDT, Actinic Cheilitis, Phase 2 Clinical Trial
- Medical subject headings
- Actinic cheilitis, Leukoplakia, Erythroplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metil 5-aminolevulinateDrug
Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.
| Study group | Role | What they receive |
|---|---|---|
| Metil 5-aminolevulinate arm | Experimental | Metil 5-aminolevulinate arm with photo activation. Receives: Drug: Metil 5-aminolevulinate |
| Placebo arm | Placebo comparator | Placebo (without metil 5-aminolevulinate) arm with photo activation. Receives: Drug: Metil 5-aminolevulinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical response
Expected complete clinical response in 60% of cases
Measured: 18 months
Histological cure
Expected histological cure in 40% of cases
Measured: 18 months
Secondary outcomes (1)
IHC analysis
Expression of immunohistochemical markers of cancer progression
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start17 Oct 2019 (estimated)
- Primary completion15 May 2020 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic CheilitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniel Cohen Goldenberg, Instituto Nacional de Cancer, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990636
- Sponsor's protocol ID
- INCABrazilCOPQ
- Acronym
- PDTMALAC
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03990636
- Acronym / sponsor ID
- PDTMALAC / INCABrazilCOPQ
- Conditions
- Actinic Cheilitis, Leukoplakia, Erythroplakia
- Keywords
- PDT, Actinic Cheilitis, Phase 2 Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 17 Oct 2019 (estimated)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metil 5-aminolevulinate arm | Experimental | Drug: Metil 5-aminolevulinateMetil 5-aminolevulinate arm with photo activation. |
| Placebo arm | Placebo comparator | Drug: Metil 5-aminolevulinatePlacebo (without metil 5-aminolevulinate) arm with photo activation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Histopathological diagnosis of squamous cell carcinoma (SCC)
- Patient presenting any type of immunosupression
- Recurrent crust of the lip vermilion (high risk of SCC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metil 5-aminolevulinateScrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light. | Drug | Metil 5-aminolevulinate arm, Placebo arm |
Primary outcome
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
1 secondary outcome
IHC analysis
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metil 5-aminolevulinate in people with Actinic Cheilitis and Leukoplakia, run by Instituto Nacional de Cancer, Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Cohen Goldemberg, PhD (+5521988167978, daniel.cohen@inca.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical response (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.