Cutaneous LeishmaniasisPhase 1/2AnfoleishNCT01845727
Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia
A Phase 1/2 study testing Topical Amphotericin B at 3% in people with Cutaneous Leishmaniasis, run by Drugs for Neglected Diseases at 1 site in Colombia.
Trial summary
The proposed study encompasses a two-step approach. The first aiming to determine the safety of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in having and indication of the efficacy of the two… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Topical Amphotericin B at 3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2014to Jul 2016
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject with a confirmed infection due to L. braziliensis by polymerase chain reaction assay
- Subject has a lesion that satisfies the following criteria:
- ulcerative in character
- ulcer size equal or more than 0.5 cm and 3 cm (Longest diameter)
- not located on the ear, face, close to mucosal membranes, joints or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
- Subject with up to 3 lesions.
- Duration of lesion less than 3 months by patient history
- Subject able to give written informed consent and that the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Who cannot join
- Female with a positive serum pregnancy test at screening or who is breast feeding, lactating or female at fertile age who does not agree to take appropriate contraception during treatment period up to Day 45.
- History of clinically significant medical problems or treatment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
- Within 8 weeks (56 days) of starting study treatments, received treatment for leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection
- Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
- History of known or suspected hypersensitivity or idiosyncratic reactions to amphotericin
- Has laboratory values at screening as follow: Haemoglobin below 10 grams, Serum creatinine above normal level, alanine aminotransferase and or aspartate aminotransferase 3 times above normal range
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Programa de Estudios y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia
Medellín
About this study
Official title: Safety, Pharmacokinetics, and Efficacy of Topical 3% Amphotericin B Cream for the Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia
The proposed study encompasses a two-step approach. The first aiming to determine the safety of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in having and indication of the efficacy of the two above mentioned regimens of Topical 3% Amphotericin B Cream
For the first step, 30 subjects will be randomly assigned to receive direct observed treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each group) have been enrolled and completed the 28 day treatment course. An interim analysis of all safety (Adverse Events, including local reactions and lab parameters) and pharmacokinetics collected on subjects who were randomized will be performed by data safety monitoring board. If no serious adverse events (SAEs) related to the study drug are identified on the first 30 subjects by the end of the treatment course, 50 additional subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three or two times per day for 28 days
Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day 180 for final analysis of efficacy.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Topical Amphotericin B at 3%
- Keywords
- Cutaneous leishmaniasis, Topical treatment, Colombia
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Amphotericin B at 3%Drug
Also called Anfoleish
| Study group | Role | What they receive |
|---|---|---|
| Topical Amphotericin B three times per day | Experimental | Anfoleish applied 3 times per day for 4 weeks (TID group) Receives: Drug: Topical Amphotericin B at 3% |
| Topical Amphotericin B two times per day | Experimental | Anfoleish applied 2 times per day for 4 weeks (BID group) Receives: Drug: Topical Amphotericin B at 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day.
Local adverse events including erythema/redness, swelling/oedema, and vesicles will be scored according the following criteria:
Grade 1: Visibly present but not associated with any other symptoms. Grade 2: Visibly present, large area around lesion site, and associated with other symptoms such as itching or pain. Medical intervention may be required.
Grade 3: Severe symptoms that require medical discontinuation of the study drug.
Measured: At the end of treatment (Day 28)
Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day
Cure is defined as 100% re-epithelialization of the lesion(s) by Day 90.
Measured: Day 90
Secondary outcomes (2)
Determination of Amphotericin B Cmax and Tmax in subjects treated with Anfoleish three or two times per day.
Measured: Day 45
Proportion and severity of laboratory adverse events of Anfoleish or vehicle when applied three or two times per day
Laboratory adverse events are limited to monitoring serum levels of creatinine, alanine aminotransferase and aspartate aminotransferase.
Measured: At the end of treatment (Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Dario Velez, Prof, Principal investigator, PECET, Universidad de Antioquia, Medellin, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845727
- Sponsor's protocol ID
- DNDi-CL-TF001
- Acronym
- Anfoleish
- Status last verified
- Jul 2016
- First submitted
- 24 Apr 2013
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez L, Velez I, Asela C, Cruz C, Alves F, Robledo S, Arana B. A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia. PLoS Negl Trop Dis. 2018 Jul 25;12(7):e0006653. doi: 10.1371/journal.pntd.0006653. eCollection 2018 Jul.
PubMed 30044792
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics, and Efficacy of Topical 3% Amphotericin B Cream for the Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia
- ClinicalTrials.gov ID
- NCT01845727
- Acronym / sponsor ID
- Anfoleish / DNDi-CL-TF001
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Cutaneous leishmaniasis, Topical treatment, Colombia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 May 2013 (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 proposed study encompasses a two-step approach. The first aiming to determine the safety of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in having and indication of the efficacy of the two above mentioned regimens of Topical 3% Amphotericin B Cream
For the first step, 30 subjects will be randomly assigned to receive direct observed treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each group) have been enrolled and completed the 28 day treatment course. An interim analysis of all safety (Adverse Events, including local reactions and lab parameters) and pharmacokinetics collected on subjects who were randomized will be performed by data safety monitoring board. If no serious adverse events (SAEs) related to the study drug are identified on the first 30 subjects by the end of the treatment course, 50 additional subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three or two times per day for 28 days
Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day 180 for final analysis of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Amphotericin B three times per day | Experimental | Drug: Topical Amphotericin B at 3%Anfoleish applied 3 times per day for 4 weeks (TID group) |
| Topical Amphotericin B two times per day | Experimental | Drug: Topical Amphotericin B at 3%Anfoleish applied 2 times per day for 4 weeks (BID group) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject with a confirmed infection due to L. braziliensis by polymerase chain reaction assay
- Subject has a lesion that satisfies the following criteria:
- ulcerative in character
- ulcer size equal or more than 0.5 cm and 3 cm (Longest diameter)
- not located on the ear, face, close to mucosal membranes, joints or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
Key exclusion criteria (6 listed)
- Female with a positive serum pregnancy test at screening or who is breast feeding, lactating or female at fertile age who does not agree to take appropriate contraception during treatment period up to Day 45.
- History of clinically significant medical problems or treatment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
- Within 8 weeks (56 days) of starting study treatments, received treatment for leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection
- Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
- History of known or suspected hypersensitivity or idiosyncratic reactions to amphotericin
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 at 3%Also: Anfoleish | Drug | Topical Amphotericin B three times per day, Topical Amphotericin B two times per day |
Primary outcome
Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day.
Time frame: At the end of treatment (Day 28)
Local adverse events including erythema/redness, swelling/oedema, and vesicles will be scored according the following criteria: Grade 1: Visibly present but not associated with any other symptoms. Grade 2: Visibly present, large area around lesion site, and associated with other symptoms such as itching or pain. Medical intervention may be required. Grade 3: Severe symptoms that require medical discontinuation of the study drug.
Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day
Time frame: Day 90
Cure is defined as 100% re-epithelialization of the lesion(s) by Day 90.
2 secondary outcomes
Determination of Amphotericin B Cmax and Tmax in subjects treated with Anfoleish three or two times per day.
Time frame: Day 45
Proportion and severity of laboratory adverse events of Anfoleish or vehicle when applied three or two times per day
Time frame: At the end of treatment (Day 28
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 Jul 2016.
- Derived from this study: PubMed 30044792Lopez L, Velez I, Asela C, Cruz C, Alves F, Robledo S, Arana B. A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia. PLoS Negl Trop Dis. 2018 Jul 25;12(7):e0006653. doi: 10.1371/journal.pntd.0006653. eCollection 2018 Jul.
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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.
Ivan Dario Velez, Prof principal investigator
PECET, Universidad de Antioquia, Medellin, Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical Amphotericin B at 3% in people with Cutaneous Leishmaniasis, run by Drugs for Neglected Diseases at 1 site in Colombia.
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 6 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 Jul 2016. 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 Colombia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day. (time frame: At the end of treatment (Day 28)). 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?
On the ClinicalTrials.gov record for NCT01845727, which also lists 1 linked publication.
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 Jul 2016.