LeishmaniasisPhase 2NCT02656797
Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
A Phase 2 study testing Topical Amphotericin-B 0.4% liposomal gel in people with Leishmaniasis, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- Topical Amphotericin-B 0.4% liposomal gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jan 2018to 1 Oct 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
- Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
- 1 to 5 lesions
- Signed informed consent
Who cannot join
- Facial lesions
- Significant co-morbidity
- Pregnancy or breast-feeding at enrollment
- Previous treatment for leishmaniasis
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.
Read the detailed description
Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.
Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.
- Conditions
- Leishmaniasis
- Being tested
- Topical Amphotericin-B 0.4% liposomal gel
- Keywords
- Leishmania major, Leishmania tropica, Amphotericin B
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Amphotericin-B 0.4% liposomal gelDrug
Topical Amphotericin-B 0.4% liposomal gel
| Study group | Role | What they receive |
|---|---|---|
| AM-B | Experimental | Topical Amphotericin-B 0.4% liposomal gel Receives: Drug: Topical Amphotericin-B 0.4% liposomal gel |
| Placebo | Placebo comparator | Placebo gel preparation Receives: Drug: Topical Amphotericin-B 0.4% liposomal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete re-epithelization
Absence of ulceration, induration, erosion and
Measured: Day 28 from enrollement
Secondary outcomes (4)
Lesion size
Defined by the multiplication of lesion length and width
Measured: Day 28 and day 56 from enrollement
Complete re-epithelization
Measured: Day 28 from enrollement
Skin manifestations
Pruritus, pain, etching, discharge, bloating
Measured: Day 28 and day 56 from enrollement
Evidence of lesihmania infection
Evaluated by PCR test from a sample acquired from the lesion
Measured: Day 56 from enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start30 Jan 2018
- Primary completion1 Jun 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR HOREV, Soroka University Medical Center
- Investigators
- Amir Horev, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656797
- Sponsor's protocol ID
- sor017715ctil
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2016
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT02656797
- Acronym / sponsor ID
- sor017715ctil
- Conditions
- Leishmaniasis
- Keywords
- Leishmania major, Leishmania tropica, Amphotericin B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 15 Jan 2016 (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.
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.
Detailed description
Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.
Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM-B | Experimental | Drug: Topical Amphotericin-B 0.4% liposomal gelTopical Amphotericin-B 0.4% liposomal gel |
| Placebo | Placebo comparator | Drug: Topical Amphotericin-B 0.4% liposomal gelPlacebo gel preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
- 1 to 5 lesions
- Signed informed consent
Key exclusion criteria (4 listed)
- Facial lesions
- Significant co-morbidity
- Pregnancy or breast-feeding at enrollment
- Previous treatment for leishmaniasis
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 |
|---|---|---|
| Topical Amphotericin-B 0.4% liposomal gelTopical Amphotericin-B 0.4% liposomal gel | Drug | AM-B, Placebo |
Primary outcome
Complete re-epithelization
Time frame: Day 28 from enrollement
Absence of ulceration, induration, erosion and
4 secondary outcomes
Lesion size
Time frame: Day 28 and day 56 from enrollement
Complete re-epithelization
Time frame: Day 28 from enrollement
Skin manifestations
Time frame: Day 28 and day 56 from enrollement
Evidence of lesihmania infection
Time frame: Day 56 from enrollement
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 15 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Amir Horev, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Amphotericin-B 0.4% liposomal gel in people with Leishmaniasis, run by Soroka University Medical Center at 1 site in Israel.
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 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 15 Mar 2022. 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 Israel. 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?
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?
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 re-epithelization (time frame: Day 28 from enrollement). 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 15 Mar 2022.