Cutaneous LeishmaniasisEarly Phase 1NCT01050777
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
A Early Phase 1 study testing Liposomal meglumine antimoniate (Glucantime), Liposomal meglumine antimoniate and Liposomal Paromomycin in people with Cutaneous Leishmaniasis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Liposomal meglumine antimoniate (Glucantime), Liposomal meglumine antimoniate and Liposomal Paromomycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Mar 2012
- Phase
- Early Phase 1
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female aged between 12 to 60 years.
- Parasitologically proven CL due to L. tropica.
- History of failure to at least one full course of systemic Glucantime.
- In general good health based on history and physical examination.
- Number of lesion at most 4.
- Lesion size less than 3 cm.
- Signed informed consent voluntarily and knowingly.
- Guardian's signature for volunteer less than 18 years old.
Who cannot join
- Pregnant or lactating women and those who are planning to be pregnant in next 60 days.
- Use of other types of treatment for CL.
- Involvement in any other drug or vaccine trial during the study period.
- Known heart, kidney, liver diseases based on history and physical exam. Abnormal ECG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Efficacy of Topical Nano-liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica
Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the first-line treatment of CL which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Several lipid-based formulations have been developed to treat experimental leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal formulation of Glucantime were prepared and showed high efficacy in vivo against L. major infection in BALB/c mice.
In this study the efficacy of liposomal formulation of PM or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Liposomal meglumine antimoniate (Glucantime), Liposomal meglumine antimoniate, Liposomal Paromomycin, Placebo
- Keywords
- Cutaneous Leishmaniasis caused by l. tropica
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal meglumine antimoniate (Glucantime)Drug
Liposomes containing meglumine antimoniate
Liposomal meglumine antimoniateDrug
Liposomal form of meglumine antimoniate
Liposomal ParomomycinDrug
Liposomal form of 10% Paromomycin
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Paromomycin | Experimental | Liposomes containing 10% Paromomycin Receives: Drug: Liposomal meglumine antimoniate; Drug: Liposomal Paromomycin |
| Liposomal meglumine antimoniate | Experimental | Liposomes containing meglumine antimonate Receives: Drug: Liposomal meglumine antimoniate (Glucantime); Drug: Liposomal meglumine antimoniate |
| Placebo | Placebo comparator | Not described Receives: Drug: Liposomal meglumine antimoniate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure equal to Complete Re-epithelization of all lesions
Measured: 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionMar 2012
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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences, Center for Research and Training in Skin Diseases and Leprosy
- Responsible party
- Principal investigator, Ali Khamesipour, Tehran University of Medical Sciences
- Investigators
- Masud Maleki, MD, Principal investigator, Mashhad University of Medical Sciences, Mashhad, IranAli Khamesipour, MPH, PhD, Principal investigator, Center for Research & Training in Skin Diseases & Leprosy, TUMSMahmoud Reza Jaafari, Parm D, PhD, Principal investigator, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050777
- Sponsor's protocol ID
- 86783
- Status last verified
- Feb 2011
- First submitted
- 13 Jan 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Efficacy of Topical Nano-liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica
- ClinicalTrials.gov ID
- NCT01050777
- Acronym / sponsor ID
- 86783
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Cutaneous Leishmaniasis caused by l. tropica
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences, Center for Research and Training in Skin Diseases and Leprosy
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Jan 2010 (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.
Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the first-line treatment of CL which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Several lipid-based formulations have been developed to treat experimental leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal formulation of Glucantime were prepared and showed high efficacy in vivo against L. major infection in BALB/c mice.
In this study the efficacy of liposomal formulation of PM or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liposomal Paromomycin | Experimental | Drug: Liposomal meglumine antimoniate, Drug: Liposomal ParomomycinLiposomes containing 10% Paromomycin |
| Liposomal meglumine antimoniate | Experimental | Drug: Liposomal meglumine antimoniate (Glucantime), Drug: Liposomal meglumine antimoniateLiposomes containing meglumine antimonate |
| Placebo | Placebo comparator | Drug: Liposomal meglumine antimoniate, Drug: Placebo |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Male or female aged between 12 to 60 years.
- Parasitologically proven CL due to L. tropica.
- History of failure to at least one full course of systemic Glucantime.
- In general good health based on history and physical examination.
- Number of lesion at most 4.
Key exclusion criteria (4 listed)
- Pregnant or lactating women and those who are planning to be pregnant in next 60 days.
- Use of other types of treatment for CL.
- Involvement in any other drug or vaccine trial during the study period.
- Known heart, kidney, liver diseases based on history and physical exam. Abnormal ECG.
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 |
|---|---|---|
| Liposomal meglumine antimoniate (Glucantime)Liposomes containing meglumine antimoniate | Drug | Liposomal meglumine antimoniate |
| Liposomal meglumine antimoniateLiposomal form of meglumine antimoniate | Drug | Liposomal Paromomycin, Liposomal meglumine antimoniate, Placebo |
| Liposomal ParomomycinLiposomal form of 10% Paromomycin | Drug | Liposomal Paromomycin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Complete cure equal to Complete Re-epithelization of all lesions
Time frame: 200 days
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 20 Jun 2012.
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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.
Masud Maleki, MD principal investigator
Mashhad University of Medical Sciences, Mashhad, Iran
Ali Khamesipour, MPH, PhD principal investigator
Center for Research & Training in Skin Diseases & Leprosy, TUMS
Mahmoud Reza Jaafari, Parm D, PhD principal investigator
Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Liposomal meglumine antimoniate (Glucantime), Liposomal meglumine antimoniate and Liposomal Paromomycin in people with Cutaneous Leishmaniasis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 8 inclusion and 4 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 20 Jun 2012. 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 Iran. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Complete cure equal to Complete Re-epithelization of all lesions (time frame: 200 days). 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 20 Jun 2012.