Cutaneous LeishmaniasisPhase 2/3NCT01381055
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
A Phase 2/3 study testing Pentoxifylline in people with Cutaneous Leishmaniasis, run by Paulo Roberto Lima Machado at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Oct 2015
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
- Number of lesions: 1 to 3 ulcerative lesions.
- Lesion´s diameter: 1 to 5 cm.
- Disease duration: up to three months.
Who cannot join
- Safety concerns:
- AST, ALT >3 times upper limit of normal range
- Serum creatinine or BUN >1.5 times upper limit of normal range
- Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
- Immunodeficiency or antibody to HIV
- Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
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- Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
- Lack of suitability for the trial:
- Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
- Any history of prior anti-leishmania therapy
- Any condition which compromises ability to comply with the study procedures
- Administrative reasons:
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- Anticipated non-availability for study visits/procedures
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Posto de Saúde de Corte de Pedra
Corte de Pedra, Tancredo Neves/Bahia, 40000
About this study
Official title: Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis
The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Pentoxifylline, Placebo
- Keywords
- Cutaneous leishmaniasis, Pentoxifylline, Meglumine antimoniate, L. braziliensis
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.
PlaceboDrug
Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline plus antimony | Experimental | Not described Receives: Drug: Pentoxifylline |
| Placebo plus antimony | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate or complete cicatrization of the ulcer.
All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.
Measured: 6 months
Secondary outcomes (1)
Initial cure rate or complete cicatrization of the ulcer
All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulo Roberto Lima Machado
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia
- Responsible party
- Sponsor-investigator, Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
- Investigators
- Paulo Roberto L Machado, MD, PhD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381055
- Sponsor's protocol ID
- LCPX2011
- Status last verified
- Jan 2017
- First submitted
- 23 Jun 2011
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT01381055
- Acronym / sponsor ID
- LCPX2011
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Cutaneous leishmaniasis, Pentoxifylline, Meglumine antimoniate, L. braziliensis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Paulo Roberto Lima MachadoUniversity, hospital or other
- Collaborators
- Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia
- Study start
- Mar 2012 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Jun 2011 (estimated)
- 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.
The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.
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 |
|---|---|---|
| Pentoxifylline plus antimony | Experimental | Drug: Pentoxifylline |
| Placebo plus antimony | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
- Number of lesions: 1 to 3 ulcerative lesions.
- Lesion´s diameter: 1 to 5 cm.
- Disease duration: up to three months.
Key exclusion criteria (14 listed)
- Safety concerns:
- Lack of suitability for the trial:
- Administrative reasons:
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 |
|---|---|---|
| PentoxifyllinePatients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days. | Drug | Pentoxifylline plus antimony |
| PlaceboPatients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days. | Drug | Placebo plus antimony |
Primary outcome
Cure rate or complete cicatrization of the ulcer.
Time frame: 6 months
All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.
1 secondary outcome
Initial cure rate or complete cicatrization of the ulcer
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
Paulo Roberto L Machado, MD, PhD principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pentoxifylline in people with Cutaneous Leishmaniasis, run by Paulo Roberto Lima Machado at 1 site in 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate or complete cicatrization of the ulcer. (time frame: 6 months). 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 26 Jan 2017.