Cutaneous LeishmaniasisPhase 3NCT04340128
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
A Phase 3 study testing Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Read more about this study
- Who is it for?
- Ages 9 to 70 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Meglumine antimoniate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- May 2007to Dec 2007
- Phase
- Phase 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 9 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parasitologically proven cases of CL based on positive smear and/or culture
- Otherwise healthy subjects on the basis of medical history.
- Age 9-70 years
- Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).
Who cannot join
- Pregnant or lactating women
- Duration of lesion more than 6 months
- Number of lesions more than 4
- History of allergy to Glucantime
- Serious systemic illnesses (as judged by the physician)
- Participation in any drug trials in the last 60 days
- No indication for systemic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Intra-lesional Injections of Glucantime Once Weekly in Comparison With Twice Weekly in the Treatment of Acute Anthroponotic Cutaneous Leishmaniasis (ACL)
Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. Many different modalities are used to treat the disease with a limited success. Intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. In this study the efficacy of intra-lesional injections of Glucantime weekly is compared with intra-lesional injections of Glucantime twice weekly.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Meglumine antimoniate
- Keywords
- Anthroponotic Cutaneous Leishmaniasis, L. tropica, Meglumine antimoniate (Glucantime)
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meglumine antimoniateDrug
Also called Glucantime
Intra-lesional injection once a week, 0.1/cm2
Meglumine antimoniateDrug
Also called Glucantime
Intra-lesional injection twice a week, 0.1/cm2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intra-lesional injection of Glucantime once a week Receives: Drug: Meglumine antimoniate |
| 2 | Experimental | Intra-lesional injection twice a week, 0.1/cm2 Receives: Drug: Meglumine antimoniate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing of the lesion(s)
Measured: 5 months
Secondary outcomes (1)
Partiall cure
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study startMay 2007
- Primary completionOct 2007
- Study completionDec 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences, Kerman University of Medical Sciences
- Investigators
- Alireza Khatami, MD MSPH, Study director, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical SciencesAli Khamesipour, PhD, Principal investigator, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical SciencesMahdieh Bahrami, MD, Study chair, Kerman University of Medical SciencesMohammad Hossein Ghoorchi, MD, Study chair, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340128
- Sponsor's protocol ID
- j/423/2252
- Other IDs
- 29463
- Status last verified
- Feb 2011
- First submitted
- 16 Feb 2011
- Last updated
- 9 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Intra-lesional Injections of Glucantime Once Weekly in Comparison With Twice Weekly in the Treatment of Acute Anthroponotic Cutaneous Leishmaniasis (ACL)
- ClinicalTrials.gov ID
- NCT04340128
- Acronym / sponsor ID
- j/423/2252
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Anthroponotic Cutaneous Leishmaniasis, L. tropica, Meglumine antimoniate (Glucantime)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences, Kerman University of Medical Sciences
- Study start
- May 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Apr 2020 (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.
Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. Many different modalities are used to treat the disease with a limited success. Intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. In this study the efficacy of intra-lesional injections of Glucantime weekly is compared with intra-lesional injections of Glucantime twice weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Meglumine antimoniateIntra-lesional injection of Glucantime once a week |
| 2 | Experimental | Drug: Meglumine antimoniateIntra-lesional injection twice a week, 0.1/cm2 |
Who may qualify
- Ages
- 9 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parasitologically proven cases of CL based on positive smear and/or culture
- Otherwise healthy subjects on the basis of medical history.
- Age 9-70 years
- Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Duration of lesion more than 6 months
- Number of lesions more than 4
- History of allergy to Glucantime
- Serious systemic illnesses (as judged by the physician)
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 |
|---|---|---|
| Meglumine antimoniateAlso: GlucantimeIntra-lesional injection once a week, 0.1/cm2 | Drug | 1 |
| Meglumine antimoniateAlso: GlucantimeIntra-lesional injection twice a week, 0.1/cm2 | Drug | 2 |
Primary outcome
Complete healing of the lesion(s)
Time frame: 5 months
1 secondary outcome
Partiall cure
Time frame: 5 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 9 Apr 2020.
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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.
Alireza Khatami, MD MSPH study director
Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
Ali Khamesipour, PhD principal investigator
Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
Mahdieh Bahrami, MD study chair
Kerman University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meglumine antimoniate 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 4 inclusion and 7 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 9 Apr 2020. 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. 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 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?
Complete healing of the lesion(s) (time frame: 5 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 9 Apr 2020.